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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Pearce IP BioBlast® for the week ending 20 March 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 20 March 2026 are set out below:


Aflibercept

On 19 March 2026, Formycon and Klinge announced they have entered into a settlement and licence agreement with Regeneron/Bayer for FYB203, biosimilar to Regeneron/Bayer’s… Read more here.

 

On 13 March 2026, IAM reported that Regeneron has applied to a US Court to seek discovery of manufacturing-related documents from Sam Chun Dang’s US subsidiaries for use in… Read more here.

Etanercept

On 13 March 2026, Sandoz filed an appeal with the US Court of Appeals for the Fourth Circuit, challenging the dismissal of the antitrust proceeding it had commenced in April… Read more here.

Evolocumab, Arilocumab

On 12 March 2026, Juve Patent reported that Sanofi/Regeneron and Amgen “have apparently settled” their dispute over PCSK9 inhibitors Praluent® (arilocumab) and Repatha®… Read more here.

Golimumab, Aflibercept, Vedolizumab, Pembrolizumab

During its Q4/2025 Earnings Call on 19 March 2026, Alvotech provided updates on its launch plans and regulatory applications for various biosimilars, including golimumab… Read more here.

Nivolumab

On 20 March 2026, BMS announced that Opdivo® (nivolumab) has received approvals from the FDA, in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the… Read more here.

Ranibizumab

On 19 March 2026, Chugai Pharmaceutical (a Roche subsidiary) announced that it filed a regulatory application with Japan’s Ministry of Health, Labour and Welfare for the medical… Read more here.

Semaglutide

On 21 March 2026, multiple generic semaglutide products launched on the Indian market, proclaiming “Day 1 entry” on expiry of Novo Nordisk’s core Indian patent for semaglutide… Read more here.

 

On 20 March 2026, Novo Nordisk announced that the FDA has approved its 7.2mg semaglutide injection, Wegovy® HD, for the reduction of excess body weight and maintenance… Read more here.

 

On 16 March 2026, Samsung Bioepis and its sister company, Epis NexLab, announced they have entered into a research collaboration and licence agreement with G2GBIO to … Read more here.

Tocilizumab

On 17 March 2026, Celltrion announced that the subcutaneous (SC) formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), is now available in the US… Read more here.

Ustekinumab

On 20 March 2026, Celltrion announced that it has obtained additional approval from Health Canada for an autoinjector formulation of Steqeyma®, biosimilar to Janssen’s… Read more here.

Vedolizumab

On 18 March 2026, Sandoz announced it has entered into a licence, development and commercialisation agreement with Samsung Bioepis for up to five biosimilars… Read more here.

Biopharma News

On 10 March 2026, Sandoz announced the creation of a new global biosimilar development, manufacturing and supply unit, which will come into effect on 1 April 2026… Read more here.

 

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renowned for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Maliha Hoque

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®.  She is currently completing her Juris Doctor at the University of Sydney.  With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’.  Maliha is interested in the intersection of law and science, and digital transformation.  She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

Generic Semaglutide Launches in India, including by Dr Reddy’s, Zydus, Alkem, Sun Pharma & Glenmark

On 21 March 2026, multiple generic semaglutide products launched on the Indian market, proclaiming “Day 1 entry” on expiry of Novo Nordisk’s core Indian patent for semaglutide (Ozempic®/Wegovy®).

The products launched on the Indian market include:

  • Dr Reddy’s injectable semaglutide, launched under the name Obeda™, in a pre-filled disposable pen for type 2 diabetes. According to Dr Reddy’s, it was the first Indian company to receive approval from the Drugs Controller General of India (DCGI) for generic semaglutide.  The cost to the patient will be about INR 4,200 per month.
  • Zydus Lifesciences’ Semaglyn™, Mashema™ and Alterme™. Zydus’ injectable semaglutide received DCGI approval for the treatment of both Type 2 diabetes mellitus and obesity.  The products are available in a reusable, multi-dose pen device.  The average monthly cost of the treatment will be approximately INR 2,200.  Under an agreement announced on 17 March 2026, Lupin holds semi-exclusive rights to co-market Zydus’ semaglutide injection under the brand names Semanext® and Lupin’s Livarise®.
  • Alkem Laboratories’ semaglutide injection, launched under the names Semasize™, Obesema™ and Hepaglide™. It is available in a pre-filled disposable injection pen at a price starting at INR 1,800 for a month’s dosage, which amounts to a weekly cost of about INR 450.  A reusable pen option is also available.  Alkem received DCGI approval for type 2 diabetes mellitus and chronic weight management as an adjunct to diet and exercise, subsequent to a review of its Phase 3 clinical trials conducted in India.
  • Sun Pharma’s Noveltreat™ and Sematrinity™ (semaglutide), indicated for chronic weight management and type 2 diabetes mellitus, respectively. Noveltreat™ is available in a pre-filled pen, while Sematrinity™ is provided in a multi-dose pen format.  Weekly therapy costs (from initiation to the highest dose) range from about INR 900 to 2,000 for Noveltreat™ and INR 750 to 1,300 for Senatrinity™.
  • Glenmark Pharmaceuticals’ GLIPIQ®, for the management of Type 2 diabetes mellitus. The drug received DCGI approval in both vial and pre-filled pen formulations. The expected weekly cost of treatment with GLIPIQ® vials ranges from INR 325 to INR 440.

According to Indian-English language newspaper, The Hindu, the market for semaglutide in India is estimated to be $1 billion over the next two years, with an estimate of over 100 million people in India having diabetes and an additional 136 million being pre-diabetic.

Novo Nordisk’s Wegovy® HD (Semaglutide 7.2mg) Receives FDA Approval

On 20 March 2026, Novo Nordisk announced that the FDA has approved its 7.2mg semaglutide injection, Wegovy® HD, for the reduction of excess body weight and maintenance of weight reduction long-term.  The high dose formulation is expected to be launched in the US in a single dose pen in April 2026.

Wegovy® HD received accelerated approval under the FDA Commissioner’s National Priority Voucher (CNPV) pilot program, which accelerates review and approval of products that align with a certain critical US national health priority.  Novo Nordisk’s supplemental New Drug Application for the product was submitted in November 2025.

Wegovy® 7.2mg has been approved in the EU (positive CHMP recommendation in December 2025, European Commission approved February 2026) and the UK (approved January 2026) as maintenance doses for adults with obesity.  Novo Nordisk expects regulatory decisions in the EU and the UK regarding a single-dose 7.2mg semaglutide pen in the second half of 2026.

Health Canada Approves Celltrion’s Autoinjector Formulation of Biosimilar Ustekinumab

On 20 March 2026, Celltrion announced that it has obtained additional approval from Health Canada for an autoinjector formulation of Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab).  This approval enables Celltrion to launch two additional autoinjector formulations (45mg/0.5mL and 90mg/1.0mL) in Canada.

Canada has seen significant biosimilar activity for ustekinumab.  The following products have already been approved by Health Canada:

Biosimilar Manufacturer Health Canada Approval Launch
Jamteki JAMP Pharma / Alvotech November 2023 March 2024
Wezlana Amgen December 2023 March 2024
Steqeyma Celltrion July 2024 August 2024
Pyzchiva Samsung Bioepis August 2024 Not yet launched as of reporting
Otulfi (FYB202) Formycon / Fresenius Kabi 8 January 2025 May 2025
Yesintek Biocon Biologics 17 October 2025 Mid-October 2025
Imuldosa Dong-A ST / Intas January 2026 Not yet launched in Canada

 

The US market has seen an even bigger wave of ustekinumab biosimilar activity in 2025.  By the end of the year, the FDA had approved a total of eight ustekinumab biosimilars.  The following biosimilars launched in the US during 2025:

 

Biosimilar Manufacturer US Launch Date Interchangeable Status
Wezlana (ustekinumab-auub) Amgen January 2025 Yes — first interchangeable ustekinumab biosimilar
Selarsdi (ustekinumab-aekn) Alvotech / Teva 21 February 2025 Yes
Pyzchiva (ustekinumab-ttwe) Samsung Bioepis / Sandoz 24 February 2025 Provisional — pending expiry of Wezlana’s 1-year interchangeability exclusivity
Yesintek (ustekinumab-kfce) Biocon Biologics February 2025 No
Otulfi (ustekinumab-aauz) Fresenius Kabi / Formycon 3 March 2025 Yes
Steqeyma (ustekinumab-stba) Celltrion 13 March 2025 No
Imuldosa (ustekinumab-srlf) Dong-A ST / Accord BioPharma 18 August 2025 No
Starjemza (ustekinumab-hmny) Bio-Thera Solutions / Hikma 6 November 2025 Yes

BMS’ Opdivo® Combos Approved in US & EU for cHL Indications, while Henlius’ Biosimilar Nivolumab IND Application Approved in China

On 20 March 2026, BMS announced that Opdivo® (nivolumab) has received approvals from the FDA, in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of previously untreated, Stage III or IV classical Hodgkin Lymphoma (cHL) and from the European Commission, in combination with brentuximab vedotin for the treatment of relapsed or refractory cHL after one prior line of therapy.  The European approval was recommended in January 2026.  The US approval follows the FDA’s priority review.

On the same date, Shanghai Henlius Biotech announced it has received approval from China’s National Medical Products Administration (NMPA) for the investigational new drug (IND) application for HLX18, biosimilar to Opdivo®.  This follows the US FDA approval of the IND application for HLX18 in December 2025.

A number of other nivolumab biosimilars have been launched or are in development.  Zydus was recently first to market its biosimilar, Tishtha®, in India.  At least Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars in their pipelines.

Chugai Files Regulatory Application in Japan for Ocular Implant Component of Ranibizumab Port Delivery Platform

On 19 March 2026, Chugai Pharmaceutical (a Roche subsidiary) announced that it filed a regulatory application with Japan’s Ministry of Health, Labour and Welfare for the medical device component of its Port Delivery Platform with ranibizumab.

The Port Delivery Platform comprises an ocular implant designed for the long-term, continuous release of a drug into the eye (in this case, ranibizumab).  The platform includes the implant and an insertion device, as well as ancillary devices (initial fill needle, refill needle, and explant tool).

Chugai’s regulatory application is based on the global Phase III Archway study results in patients with neovascular age-related macular degeneration (nAMD), and the global Phase 3 Pagoda study in patients with diabetic macular oedema (DME), both conducted in the US by Genentech/Roche, using their Susvimo® (ranibizumab).

Chugai’s announcement follows Genentech/Roche’s announcement in February 2025 that the FDA approved a new indication for Genentech’s Susvimo® (ranibizumab, 100 mg/ml injection) for diabetic macular oedema (DME), making it the first and only approved continuous delivery treatment for DME.  The approval was based on one-year results from the Phase 3 Pagoda study.

The FDA had first approved Susvimo® in October 2021.  However, in October 2022, Genentech launched a voluntary recall after test results showed some implants did not perform to Genentech’s standards.  Genentech has since updated the Susvimo® implant and refill needle.  DME is the second indication approved for Susvimo®, after the FDA approved its relaunch for nAMD in July 2024.

IP Australia Proposes Changes to “Streamline and Simplify” Australia’s IP System

Earlier this month IP Australia issued a consultation paper seeking submissions on proposed reforms primarily to Australia’s current IP system.  Submissions in reply to any of the below proposals or issues are due 2 April 2026.

The consultation paper has been developed in conjunction with the New Zealand Ministry of Business, Innovation and Employment (MBIE) which oversees the operation of the New Zealand Intellectual Property Office (IPONZ).

The consultation paper can be found here: Public Consultation Template

The proposals are as follows:

Proposal 1 Expanding the definition of “exclusive licensees” for patents to allow “partial” exclusive licensees to bring infringement proceedings (joined with the patentee).

The consultation paper also suggests expanding this definition in respect of designs and plant breeders’ rights (PBRs).

Proposal 2 To shorten the opposition process in respect to pharmaceutical patent extensions of term (PTE).  Currently, the Section 75 substantive opposition procedure can be lengthy.  The proposal is to amend the Patents Regulations 1991 to reclassify Section 75 as procedural oppositions whereby the Commissioner would have greater flexibility to manage the process more effectively.
Proposal 3 Currently, for both patents and trade marks, Australia has a “time to acceptance” deadline system which gives Applicants a fixed period (12 months for patents and 15 months for trade marks) to secure acceptance regardless as to how many reports and responses are filed.  The proposal is to shift to a US-style response-based deadline system.  For instance, Applicants would need to respond in a shorter period (e.g., 2 months) and the number of responses would also be limited, at which time, a final rejection procedure would commence.
Proposal 4 Allow the Commissioner to award costs in trade mark oppositions above those outlined in the schedule.  Currently, in trade mark oppositions, costs are limited to the specific amounts specified in a schedule to the regulations.  The consultation paper mentions that the reason for this proposed reform is to stamp out occasional “poor behaviour” during trade mark oppositions.
Proposal 5 Amend the Trade Marks Act 1995 and Trade Marks Regulations 1995 so that existing references to the Madrid Protocol and Regulations apply to the versions as in force and updated from time to time.  A further proposal is to also amend the Act and Regulations so that the source of the ‘class headings’ is the Nice Agreement as in force and updated from time to time. These proposals are suggested for future proofing and would remove the need for ongoing legislative amendments, ensure alignment with international systems, and provide clearer and more accurate legislative references.
Proposal 6 Provide the Registrar with better powers to finalise trade mark oppositions.  Particularly, the proposal is to amend the legislation to provide the Registrar the power to dismiss or finalise oppositions where both parties have abandoned the matter and are no longer participating.
Proposal 7 Amend the trade mark legislation to allow the Registrar to correct ownership errors before and after registration in defined circumstances (eg., where entities are closely connected or act in concert).
Proposal 8 Remove the requirement for certificates of verification for trade marks and designs.
Proposal 9 For patents, PBRs and designs, allow virtual marking of products (rather than just physical product marking), for example, by QR code, barcode and URL.
Proposal 10 Amend the Plant Breeder’s Rights Act 1994 (PBR Act) to introduce a 6 month, non-extendable grace period for payment of renewal fees (like for patents).
Proposal 11 Amend the PBR Act to repeal the mandatory herbarium deposit requirement for native plant varieties.  Deposits would instead become voluntary.
Proposal 12 Provide the Commissioner with greater powers to investigate, discipline and govern deregistered IP attorneys.
Proposal 13 Currently, the Patents Acts of both AU and NZ require registered patent attorneys to be in regular attendance at their office and in continuous charge of the patents work undertaken there.  The proposal is to amend or repeal provisions (in both AU and NZ) to make it clear that an attorney may supervise and be “in attendance” either physically or remotely.

 

Section B of the consultation paper sets out the following policy issues on which IP Australia has no set view, but has asked for comments nonetheless:

Issue 1 Removing the declaration requirement for initial short extensions of time (under Section 223) and limiting the time patents can be revived with an extension of time.
Issue 2 Reforming patent timeframes by giving 3rd parties greater powers to intervene in the patent application process.  The consultation paper also mentions a possible reform to the current flexibilities surrounding Australian divisional filing practice.
Issue 3 Amend the designs legislation to streamline and reduce complexity in how applications for more than one design are handled after filing.
Issue 4 Increase the flexibility for filing excluded designs.
Issue 5 Clarifying exhaustion (Section 23) in the PBR Act.
Issue 6 Clarifying how PBRs apply where harvested material is also propagating material.

 

Submissions in reply to any of the above proposals or issues are due 2 April 2026.

If you would like assistance or have any questions regarding this consultation paper, please do not hesitate to contact us.

 


About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Mathew Lucas

Mathew Lucas

Executive, Patent & Trade Mark Attorney (AU, NZ)

Mathew Lucas is an Executive Patent & Trade Mark Attorney with over 25 years’ experience in patent prosecution, oppositions, freedom-to-operate advice, litigation support, and strategic IP advice, focusing on the life sciences sector including pharma/biopharma, chemistry, materials science, diagnostics and biotechnology.  He has drafted more than 500 patent specifications across a wide range of technologies.

Mat holds a PhD in Chemistry from the University of Melbourne and completed post-doctoral research at the University of Illinois (Chicago) and the University of Adelaide in areas including radical chemistry, diagnostic technologies and therapeutic compounds.

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand.  Paul appears in cases before the New Zealand Court of Appeal and High Court of New Zealand, as well as the New Zealand Intellectual Property Office and IP Australia

Paul is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment. Paul is recommended for litigation in the IAM Patent 1000, rated for enforcement and litigation in the WTR1000, ranked for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

Sally Paterson

Sally Paterson

Executive, Lawyer (NZ), Patent & Trade Mark Attorney (AU, NZ)

Sally is a senior Trans-Tasman Patent and Trade Mark Attorney, and a New Zealand registered lawyer with over 20 years’ experience in IP.  Sally’s particular expertise is in life sciences, drawing from her background in biological sciences. Sally is well respected in the New Zealand IP community for her broad ranging skills in all aspects of intellectual property advice, protection and enforcement. Sally has extensive experience securing registration for patents, designs and trade marks in New Zealand, Australia and internationally, providing strategic infringement, validity and enforceability opinions, acting in contentious disputes including matters before the courts of New Zealand and before IPONZ and IP Australia, and advising on copyright and consumer law matters.

Alvotech Provides Updates on Launch & Regulatory Plans for Golimumab, High Dose Aflibercept, Vedolizumab and Pembrolizumab Biosimilars

During its Q4/2025 Earnings Call on 19 March 2026, Alvotech provided updates on its launch plans and regulatory applications for various biosimilars, including golimumab, aflibercept, vedolizumab and pembrolizumab.

Alvotech confirmed that Gobivaz® (AVT05) was launched in the EU in December 2025 as the first available biosimilar to J&J’s Simponi® (golimumab), following its November 2025 EU marketing authorisation.  Gobivaz® is being commercialised by Advanz Pharma in the UK and Europe under a May 2023 licence and supply agreement with Alvotech.  In Japan, Alvotech’s commercialisation partner, Fuji Pharma, is planning to launch Gobivaz® (approved in September 2025) in May 2026.  An application for approval of AVT05 has also been filed in Canada, with a decision expected in H1 2026.  To date, the application for AVT05 is the only known golimumab biosimilar application filed in Canada.

Alvotech indicated that it is aiming to file the first regulatory submission for its high dose aflibercept biosimilar, AVT29, sometime in 2026.  AVT29, biosimilar to Regeneron/Bayer’s Eylea™ 8mg/Eylea HD®, will be commercialised by Advanz Pharma in the EU and by Teva in the US.  Under settlement agreements with Regeneron/Bayer, Alvotech has a Q4/2026 US launch date for AVT06 (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg), subject to FDA approval, and various 2026 launch dates, with its partners STADA and Advanz Pharma having already launched AVT06 in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®), respectively.

Following the recent announcement of positive results from its PK study for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab), Alvotech said that it is planning to file regulatory submissions for a vedolizumab biosimilar later in 2026.  Alvotech expects to be among the first to launch an Entyvio® biosimilar and has both IV (AVT16) and SC (AVT80) formulations in development.

As previously reported, Alvotech has a biosimilar to MSD’s Keytruda® (pembrolizumab) in its pipeline, on which it is partnering with Dr Reddy’s.  During the Q4 2025 Earnings Call, Alvotech said that it is expecting it will be in a position to file a marketing authorisation application for the pembrolizumab biosimilar in 2028.

Alvotech also provided an update on the Complete Response Letters it received from the FDA in relation to its denosumab, golimumab and aflibercept biosimilars, announcing that it has undertaken a remediation project and is on track to resubmit its applications to the FDA in the first half of 2026.

EU, LATAM & APAC Launches of Formycon/Klinge’s Biosimilar Aflibercept Planned From May 2026 Following Regeneron/Bayer Settlement

On 19 March 2026, Formycon and Klinge announced they have entered into a settlement and licence agreement with Regeneron/Bayer for FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg, in Europe and key markets in the Latin American and Asia-Pacific regions.  The agreement permits launch of FYB203 in Europe and the other licensed regions from May 2026.  FYB203 is set to launch in the US in Q4/2026 following a separate settlement of BPCIA litigation in October 2025.

The recent settlement resolves all EU patent disputes related to FYB203, including in Germany where, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction against Formycon preventing the launch of FYB203 across 20 European countries until the expiry of Regeneron’s aflibercept formulation patent EP2364691.  There have also been legal proceedings in relation to FYB203 in at least the UK, Italy, Belgium, the Netherlands, and France.

FYB203 received European marketing approval in January 2025 under the brand names Ahzantive® and Baiama®.  It was developed by Formycon, and Klinge holds the exclusive commercialisation rights.

Klinge has entered into agreements with Teva Pharmaceuticals for the semi-exclusive commercialisation rights to FYB203 (as Ahzantive®) in Europe (excluding Italy) and Israel (January 2025), Horus Pharma for the semi-exclusive commercialisation rights to FYB203 (as Baiama®) in selected European countries (September 2025) and NTC for the exclusive commercialisation rights to FYB203 in Italy (November 2025).

In the Asia Pacific region, Formycon/Klinge have exclusively licensed FYB203 commercialisation rights to Lotus Pharma for various Asian countries (February 2025) and to Actor Pharmaceuticals for Australia (October 2025).  A patent revocation action brought by Actor Pharmaceuticals in Australia relating to Regeneron’s method of treatment patent AU2012205599 relating to Eylea® (with a cross-claim for infringement by Regeneron/Bayer) was discontinued by consent on 18 March 2026, presumably in connection with the recent settlement.

In Latin America, Klinge has exclusively licensed the FYB203 commercialisation rights to Uruguay-based Megalabs (October 2025).  According to Formycon, it has been working closely with Megalabs to prepare marketing applications for Latin American countries.

Biosimilars of Regeneron/Bayer’s Eylea® 2mg are already on the market around the world, including, for example, Alvotech’s Mynzepli® (launched in the UK, Canada and Japan), Amgen’s Pavblu® (available in the US), Sandoz’s Afqlir®/Enzeevu® (launched in the UKAustralia and Canada), Samsung Bioepis’ Afilivu®/Opuviz® (available in Korea) and Celltrion’s Eydenzelt® (launched in the UK and Europe).

Sandoz & Samsung Bioepis Partner on 5 Biosimilars Including Vedolizumab

On 18 March 2026, Sandoz announced it has entered into a licence, development and commercialisation agreement with Samsung Bioepis for up to five biosimilars, including vedolizumab.

Under the agreement, Sandoz will have exclusive rights to commercialise the biosimilars globally (excluding China, Hong Kong, Taiwan, Macau and the Republic of Korea), while Samsung Bioepis will be responsible for development, manufacturing and regulatory submissions in key markets.

The first biosimilar to be licensed under the agreement will be a biosimilar to Takeda’s Entyvio® (vedolizumab).  In January 2026, Samsung Bioepis announced that it had a vedolizumab biosimilar under early-stage development.

Sandoz and Samsung Bioepis previously entered into a development and commercialisation agreement in September 2023 for Pyzchiva®/SB17, biosimilar to J&J’s Stelara® (ustekinumab).  Under that agreement, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.  Sandoz launched Pyzchiva® in Europe in July 2024 and in the US in February 2025.

In December 2025, the companies signed a commercialisation agreement for Epysqli™, biosimilar to Alexion’s Soliris® (eculizumab), for the Middle East and Africa region.

Pearce IP BioBlast® for the week ending 13 March 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 13 March 2026 are set out below:


Daratumumab, Teclistamab

On 5 March 2026, J&J announced the US approval of Tecvayli® (teclistamab-cqyv) in combination with Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of… Read more here.

Infliximab

On 11 March 2026, Celltrion announced the European launch of its Remsima® IV liquid formulation, biosimilar to Janssen’s Remicade® (infliximab).  This follows the November… Read more here.

Pertuzumab

On 10 March 2026, The Pharma Letter reported that Roche subsidiary, Genentech, had begun legal proceedings before the Moscow Arbitration Court alleging patent infringement… Read more here.

Secukinumab

On 13 March 2026, Novartis received FDA approval for Cosentyx® (secukinumab) for the treatment of moderate to severe Hidradenitis Suppurativa (HS) in paediatric patients aged… Read more here.

BioPharma Market

On 9 March 2026, the FDA issued a new draft guidance on biosimilar development and the BPCIA aimed at reducing upfront research and development timelines and costs for… Read more here.

 

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renowned for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand.  Paul appears in cases before the New Zealand Court of Appeal and High Court of New Zealand, as well as the New Zealand Intellectual Property Office and IP Australia

Paul is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment. Paul is recommended for litigation in the IAM Patent 1000, rated for enforcement and litigation in the WTR1000, ranked for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

Maliha Hoque

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®.  She is currently completing her Juris Doctor at the University of Sydney.  With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’.  Maliha is interested in the intersection of law and science, and digital transformation.  She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

Celltrion’s Tocilizumab Biosimilar SC Formulation Launched in US

On 17 March 2026, Celltrion announced that the subcutaneous (SC) formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), is now available in the US.  The SC formulation is approved for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.  Avtozma® SC formulation is available in a single-dose prefilled syringe or a single-dose prefilled autoinjector.

Both the subcutaneous and intravenous formulations of Avtozma® were FDA approved in January 2025, with the IV formulation launched in October 2025.  In December 2025, Celltrion secured reimbursement coverage for Avtozma® IV in the US, with patient reimbursement available from January 2026.

Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation approved September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation approved March 2024; IV formulation launched April 2024; SC formulation launched July 2024).  Fresenius Kabi’s Tyenne® SC was the first SC tocilizumab formulation to launch in the US.

Celltrion’s Avtozma® was the first tocilizumab biosimilar to be approved in Korea in December 2024.  In the same month, Avtozma® received a positive recommendation by the EMA’s CHMP and subsequently gained European Commission approval in February 2025.  The biosimilar has also been granted marketing approval in other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025), Japan (September 2022) and New Zealand (December 2025).  It was recommended for listing on Australia’s Pharmaceutical Benefits Scheme at PBAC’s November 2025 meeting.

Samsung Bioepis & G2GBIO Ink Deal for Development of Long-Acting Semaglutide

On 16 March 2026, Samsung Bioepis and its sister company, Epis NexLab, announced they have entered into a research collaboration and licence agreement with G2GBIO to develop long-acting semaglutide.  G2GBIO specialises in the development of sustained-release formulations using a “long-acting microsphere platform”.

Under the agreement, Samsung Bioepis will obtain full licence rights to the novel long-acting semaglutide and will have an option to licence another undisclosed G2GBIO asset.  Samsung Bioepis will also receive first negotiation rights for three yet-to-be-determined novel assets.  Epis NexLab will be responsible for the co-development of the long-acting microsphere drug delivery platform using G2GBIO’s proprietary technology.

There has been growing interest in the semaglutide space as key Novo Nordisk patents are set to expire in multiple markets in 2026, including India, China and Canada.  In January 2026, Sun Pharma, Zydus Lifesciences and Alkem Laboratories received approval in India to manufacture and sell generic versions of Novartis’ Wegovy® and Ozempic®.  According to Zydus, it plans to launch its Semaglutide Injection (15mg/3ml) in India under the brand names Semaglyn™, Mashema™ and Alterme™ “upon semaglutide patent expiry” on 20 March 2026.

New Indication Alert: Novartis’ Cosentyx® Approved for Paediatric Patients (12+) with HS

On 13 March 2026, Novartis received FDA approval for Cosentyx® (secukinumab) for the treatment of moderate to severe Hidradenitis Suppurativa (HS) in paediatric patients aged 12 years and older.  According to Novartis, Cosentyx® is the only IL-17A inhibitor approved for this age group.

This approval enables earlier intervention for adolescents with HS, who currently have fewer treatment options compared to adults.  HS often emerges during adolescence and can cause irreversible damage if left untreated, so this expanded indication is expected to improve patient access and outcomes.

In October 2023, the FDA approved Cosentyx® to treat moderate to severe HS in adults.  In the same month, the National Institute for Health and Care Excellence (NICE) in England and Wales recommended Cosentyx® for moderate to severe HS.

There are a number of secukinumab biosimilars currently under development, including by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Bio-Thera (phase 1 trial completed in 2023 and phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

Regeneron Seeks US Discovery for Patent Litigation in Taiwan Regarding Sam Chun Dang’s Biosimilar Aflibercept

On 13 March 2026, IAM reported that Regeneron has applied to a US Court to seek discovery of manufacturing-related documents from Sam Chun Dang’s (SCD’s) US subsidiaries for use in its patent infringement litigation in Taiwan regarding SCD’s biosimilar to Regeneron’s Eylea® (aflibercept), 2mg.  Regeneron has made the application for Section 1782 discovery under US legislation that permits a party involved in non-US legal proceedings to obtain documents from a company residing in the US under relevant circumstances.

The Taiwanese patent infringement litigation was commenced by Regeneron in February 2026 against the Taiwanese manufacturer of SCD’s aflibercept biosimilar, SCD411.

Regeneron and Sam Chun Dang settled their US aflibercept litigation in February 2026.  In the US, SCD has granted exclusive commercialisation rights for SCD411 to Fresenius Kabi under a December 2024 licence agreement, which also covers Brazil, Argentina, Chile Paraguay, Colombia and Mexico.  The settlement permits SCD/Fresenius to launch Vygenfree™/SCD411 in the US at an undisclosed time.  Vygenfree™/SCD411 has not yet been approved in the US.  The FDA accepted SCD’s application for SCD411 for review in December 2025.

In July 2025, the Seoul Central District Court refused Regeneron/Bayer’s request for an order that SCD submit various documents and information in connection with a lawsuit alleging that SCD’s licence agreement with an unnamed overseas company to supply SCD411 constituted infringement of Regeneron’s Korean Patent 659477.

SCD411 was approved in vial and pre-filled syringe (PFS) forms in Japan and Korea in September 2025, in Canada in June 2025 and in Europe in August 2025.  At the time of the European approval, SCD considered it may be the first to launch a PFS aflibercept biosimilar in Europe, after being the first to do so in Canada.  SCD reportedly licensed SCD411 to Apotex for the Canadian market (August 2023), to an unnamed distributor for Austria, Germany, Italy, Spain and Switzerland (November 2023), and to a further unnamed distributor for the UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland (March 2024).

Sandoz Appeals US Court’s Dismissal of Antitrust Claim Against Amgen Relating to Biosimilar Etanercept

On 13 March 2026, Sandoz filed an appeal with the US Court of Appeals for the Fourth Circuit, challenging the dismissal of the antitrust proceeding it had commenced in April 2025 alleging that Amgen “unlawfully extended and entrenched its monopoly” for Enbrel® by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”.

The US District Court for the Eastern District of Virginia dismissed Sandoz’s antitrust claim on 17 February 2026, and entered judgment in favour of Amgen.  It is this judgment from which Sandoz now appeals.

Sandoz’s complaint relates to Amgen’s purchase of exclusive US rights to certain etanercept-related patents owned by Roche (referred to as the Brockhaus Patents).  According to Sandoz, the purchase of those rights was anti-competitive, as was Amgen’s use of certain Brockhaus Patents (US 8,063,182 and US 8,163,522, having a latest expiry date in 2029) to “eliminate competition in the US etanercept market by blocking biosimilar entrants, including Sandoz”.

Amgen commenced BPCIA litigation against Sandoz in February 2016, including for infringement of the ‘182 and ‘522 patents.  Erelzi® was FDA approved in August 2016.  The ‘182 and ‘522 patents were held to be valid and infringed, and Sandoz was prevented from launching Erelzi® in the US by way of an injunction that remains in place until 2029.  In the antitrust litigation, Sandoz argues that “were it not for Amgen’s unlawful acquisition” of the Brockhaus Patents, Sandoz “would have launched its etanercept biosimilar in the US at least as early as 2019” (when certain Amgen patents expired).

The only other etanercept biosimilar approved in the US is Samsung Bioepis’ Eticovo® (April 2019).  Samsung Bioepis is prevented from launching Eticovo® in the US until 2029 by a permanent injunction granted in November 2021.

Etanercept biosimilars have been launched in other jurisdictions, including the UK (e.g. Samsung Bioepis’ Benepali® in February 2016), Europe (e.g. Biocon/Lupin’s Nepexto® in August 2020) and Canada (e.g. Sandoz/Lupin’s Rymti® in May 2024).  There are multiple etanercept biosimilars in the Australian market listed on the PBS, including Sandoz’s Erelzi® (approved November 2017PBS-listed as of October 2025), Biocon Biologics’ Nepexto® (launched in July 2025PBS-listed as of July 2025) and Samsung Bioepis’ Brenzys®, which was previously distributed in Australia by Arrow Pharmaceuticals (approved by TGA in July 2016PBS-listed as of April 2017).  However, judgment in an Australian patent infringement proceeding brought by Pfizer in relation to Samsung Bioepis’ Brenzys®, heard in September/October 2025, is yet to be delivered.

The One That Got Away – Aussie Fashion Designer Wins Trade Mark Stoush Against Katy Perry

 

Date of decision: 11 March 2026
Body: High Court of Australia
Adjudicator:
Gordon ACJ, Steward, Gleeson, Jagot, Beech-Jones JJ

Introduction

The battle of the KATY(IE) PERRY trade marks has been ongoing since 2019, but thankfully the High Court of Australia has now settled the issue once and for all.  In a decision handed down on Wednesday (11 March 2026), the High Court held that use of the Australian fashion designer’s KATIE PERRY trade mark for clothing would not confuse or deceive consumers in light of the reputation of the singer-songwriter’s KATY PERRY trade mark in Australia.  The KATIE PERRY trade mark will remain registered and in force.

Background

The background to this matter is complex and long and dates back as far as 2007, with the Federal Court of Australia and the Full Court of the Federal Court of Australia considering the issues before the High Court stepped in.

The key dates are set out below for ease of understanding the High Court’s decision:

Aussie designer – KATIE PERRY mark American popstar and celebrity – KATY PERRY mark
April-May 2007 – Aussie designer registered KATIE PERRY as a business name and domain name and begins producing clothing for sale under the brand name KATIE PERRY  
13 September 2007 – trade mark application filed for a fancy logo trade mark featuring the words KATIE PERRY in cursive font for “clothing and fashion designing”  
  November 2007 – Singer-songwriter Katheryn Hudson began performing as KATY PERRY in the US
  17 June 2008 – 2nd KATY PERRY album released and the popstar’s commercial and career momentum increased
July 2008 – Aussie fashion designer learns about the popstar by hearing the song “I Kissed A Girl” on the radio July 2008 – the popstar’s management team began to consider selling KATY PERRY-branded merchandise in countries where the popstar’s music was popular, including in Australia
Sometime in August 2008 – Aussie fashion designer realises she has not paid the registration fee for the September 2007 application and also realises that it would have been better to file a trade mark application for the word mark KATIE PERRY for clothes so allows the September 2007 application to lapse.  
  6 September 2008 – first merchandise concept was ready for production
  9 September 2008 – first KATY PERRY world tour commenced.

29 September 2008 – the fashion designer files application for KATIE PERRY for clothes (the Designer’s Mark)

This is the relevant date for assessing section 60 reputation

 
 

October 2008 – KATY PERRY-branded merchandise website went live and Australian consumers could access the website and purchase KATY PERRY merchandise.

Australian leg of the tour ran between 10 and 14 October 2008.

18 December 2008 – the Designer’s Mark receives an early notice of acceptance and is awaiting formal acceptance  
  21 May 2009 – the popstar’s lawyer prepares and sends a “without prejudice” letter to the fashion designer demanding that the Designer’s Mark be withdrawn
Between 5 and 8 June 2009 – Fashion designer receives letter and is informed that the popstar has requested an extension of time to oppose registration of the Designer’s Mark  
  15 June 2009 – a different set of lawyers for the popstar send a cease and desist letter to the fashion designer, enclosing draft proceedings for the Supreme Court of Queensland
  26 June 2009 – the popstar files a trade mark application to register the words KATY PERRY in Classes 9, 25 and 41 for music recordings, clothing and entertainment services (Singer’s Mark)
29 June 2009 – fashion designer posts message-video on her YouTube channel asking the popstar to back down  
  1 July 2009 – popstar’s lawyers propose a coexistence agreement and drafts are exchanged but ultimately abandoned
21 July 2009 – Designer’s Mark achieves registration (without opposition)  
  September 2009 – the Singer’s Mark is amended to exclude clothing and achieves registration and subsequently proceeds to registration
24 October 2019 – the fashion designer commences infringement proceedings in the Federal Court based on the sale of clothing and merchandise under the popstar’s KATY PERRY mark in Australia  
 

20 December 2019 – the popstar cross-claims seeking rectification (cancellation) of the Designer’s Mark under section 88(2)(a) and (c)

This is the relevant date for assessing section 88 grounds

Key Issues

With this background and timing in mind, the courts were asked to consider the following actions:

1. Section 60 – Whether use of the Designer’s Mark for clothing would be likely to confuse Australian consumers because of the existing level of reputation in the popstar’s KATY PERRY trade mark in Australia at 29 September 2008 (being, the filing date of the Designer’s Mark)?

2. Section 88(2)(a) – Should the Designer’s Mark be cancelled because it would be likely to confuse Australian consumers because of the existing level of reputation in the popstar’s KATY PERRY trade mark in Australia at 20 December 2019? (Basically, if section 60 were reassessed at this later date when the rectification cross-claim was commenced, would use of the Designer’s Mark be likely to confuse or deceive?)

3. Section 88(2)(c) – Should the Designer’s Mark be cancelled because use of the trade mark is likely to deceive or cause confusion because of the circumstances applying at 20 December 2019?

At first instance, Markovic J in the Federal Court found that use of the popstar’s KATY PERRY mark for clothing infringed the Designer’s Mark and that there was insufficient reputation in the popstar’s KATY PERRY trade mark at September 2008 and again at December 2019 for the Designer’s Mark to be cancelled under section 88.

The popstar’s team appealed the Federal Court decision to the Full Court of the Federal Court, with Yates, Burley and Rofe JJ finding that the Designer’s Mark should be cancelled because of the reputation existing in the popstar’s KATY PERRY mark in Australia at September 2008 and December 2019.  The Full Court’s decision overturned Markovic J’s findings, holding that the KATY PERRY mark had an extensive reputation for music, concerts and entertainment services and Australian consumers were very aware that popstars and celebrities tend to sell clothing and other wearable merchandise under their name or brand.  Because of that reputation, use of the Designer’s Mark would be likely to deceive or cause confusion and the registration should be cancelled.

The Aussie fashion designer appealed the Full Court’s decision to the High Court, asking the High Court to reverse the findings of the Full Court.

Consideration

On appeal, the High Court was asked to determine the following questions in the context of section 60, section 88 and section 89.  In the 97-page judgment handed down on 11 March 2026, Gordon A-CJ and Beech-Jones J delivered a  joint dissenting judgment; while Steward, Gleeson and Jagot JJ formed the majority, finding that Markovic J had not made any errors in the first instance decision and with each providing their own reasons for reaching the same overall conclusion.

For the sake of simplicity, we provide here a summary of the answers provided by the majority judges, Steward, Gleeson and Jagot JJ, on the key issues which formed the basis of their separate judgments upholding Markovic J’s first instance decision:

1. Can a trade mark have acquired a reputation in Australia, within the meaning of s 60 of the TM Act, other than a reputation in respect of particular goods or services?

No.  Any reputation must be a reputation in respect of particular goods and services and is tied only to those goods/services. 

2. Can a trade mark that has acquired a reputation in Australia within the meaning of s 60 of the TM Act in respect of particular goods or services be said to have also acquired a reputation in Australia in respect of other goods or services?

Not without evidence.  Even though reputation may be established in respect of one set of goods or services, that reputation does not overflow into other types of goods and services unless evidence of use establishes that the reputation also exists for the additional goods and services.  For example, the popstar’s KATY PERRY mark was found to have reputation in Australia for entertainment services and music recordings but that reputation did not automatically extend or overflow to clothing, even though it is common for popstars and celebrities to sell clothing and other merchandise under their name or brand.  The evidence showed that not a single item of KATY PERRY-branded clothing had been sold in Australia before 29 September 2008 so there could be no reputation in clothing at that date.

3. Can a registered mark be cancelled under section 88(2)(a) where the use of that registered mark would be likely to deceive or cause confusion as provided for in section 60 “because of the reputation of [another] mark” in respect of goods or services other than those in respect of which the other mark had acquired a reputation in Australia?

Yes.  Section 60 (usually an opposition ground) doesn’t require the opponent to demonstrate reputation in respect of the goods or services covered by the opposed application.  The opponent – or the party pursuing section 60 – must simply demonstrate that consumers are likely to be confused or deceived because there is a nexus between the goods and services in which the reputation has accrued and the goods and services covered by the opposed or attacked mark.  There is no requirement for the respective sets of goods and services to be the same, similar or closely related; there must simply be a sufficient nexus in the mind of consumers.

4. Where an application for rectification has been made on the section 88(2)(c) ground that “because of the circumstances applying at the time when the application for rectification is filed, the use of the registered trade mark is likely to deceive or cause confusion”, is consideration of the use of that registered trade mark confined to the actual use made of that mark at the time the application for rectification is filed?

No.  Section 88(2)(c) requires consideration of notional use at the relevant date – that is, the Court must consider “any normal and fair use across the ambit of the registration of the trade mark, be that use actual, intended or possible” (see [219]).

5. Does s 88(1) of the TM Act, which provides that “[s]ubject to subsection (2) and section 89, a prescribed court may, on the application of an aggrieved person or the Registrar, order that the Register be rectified by” cancelling the registration, provide the court with a separate source of power not to cancel a registration?

No.  The only source of power for a Court to rectify the Register (i.e. cancel a trade mark registration) comes from section 89.  There is no separate power arising from section 88(1).

6. Section 89(1) of the TM Act enables the court to “decide not to grant an application for rectification” where a ground for rectification has been established under s 88(2) “if the registered owner of the trade mark satisfies the court that the ground relied on by the applicant has not arisen through any act or fault of the registered owner“. Can the mere filing of the trade mark application for registration by the registered owner constitute an “act or fault of the registered owner”?

No, the mere filing of a trade mark application does not amount to an “act or fault” for the purpose of section 89(1).  The Full Court had determined that the fashion designer’s filing of the Designer’s Mark in circumstances where she was aware of the popstar’s KATY PERRY mark and the common practice of popstars to use their trade marks for clothing and merchandise constituted an “act or fault of the registered owner” but the High Court disagreed.

Outcome

The appeal was allowed with the orders of the Full Federal Court being set aside, with the Designer’s Mark to remain on the Register and a certain popstar being left in a slightly awkward position…


 

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

Kimberley Evans

Kimberley Evans

Executive, Lawyer (AU) & Trade Mark Attorney (AU), (Head of Trade Marks)

Kim is a lawyer and registered Trans-Tasman trade mark attorney with a wide-ranging and impressive practice background spanning private practice, in-house experience and academic activities. Kim’s clients appreciate her responsiveness, and her ability to provide clear and pragmatic branding advice that is tailored to their commercial objectives and informed by industry developments.

BREAKING NEWS – Australian High Court Grants Leave to Appeal to Otsuka in PTE Dispute

 

Date of decision: 12 March 2026
Body: High Court of Australia
Adjudicator:
Gageler CJ, Gordon, Edelman, Steward, Gleeson, Jagot, Beech-Jones JJ

BREAKING NEWS:  The High Court of Australia today granted special leave to Otsuka to appeal the decision of the Full Federal Court in Otsuka v Sun Pharma [2025].

In a victory for Sun Pharma over Otsuka regarding Sun Pharma’s generic aripiprazole, the Full Court found that a pharmaceutical substance is limited to active pharmaceutical ingredients and PTE eligibility does not extend to formulations combining those ingredients with excipients.

The Institute of Patent and Trade Mark Attorneys of Australia (IPTA) and Medicines Australia (MA) had each filed applications with the High Court seeking to intervene as amici curiae, underscoring the importance of this issue to the pharmaceutical industry.  We have previously commented on that significance here.

Given the significant shift in patent practice that the Full Court decision induced, drug manufacturers and patent professionals alike will follow the progress of Otsuka’s appeal with great interest.  We will report further as the appeal progresses.

For further information about the changes in law and practice in Australia relating to PTE and PI, see our March 2025 Masterclass here.


 

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renowned for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand.  Paul appears in cases before the New Zealand Court of Appeal and High Court of New Zealand, as well as the New Zealand Intellectual Property Office and IP Australia

Paul is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment. Paul is recommended for litigation in the IAM Patent 1000, rated for enforcement and litigation in the WTR1000, ranked for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

Sanofi/Regeneron & Amgen Settle Dispute Over PCSK9 Inhibitors, Praluent® & Repatha®

On 12 March 2026, Juve Patent reported that Sanofi/Regeneron and Amgen “have apparently settled” their dispute over PCSK9 inhibitors Praluent® (arilocumab) and Repatha® (evolocumab).  No announcements have been made by the companies and there are no details available regarding the terms of any settlement.

The dispute dates from at least 2014, when Amgen commenced US litigation against Sanofi/Regeneron, alleging that Praluent® infringed genus claims of Amgen’s patents relating to Repatha®.  In January 2017, the US District Court in Delaware granted Amgen’s request for a permanent injunction prohibiting Sanofi/Regeneron from infringing two of Amgen’s Repatha® patents.  However, in May 2023, the US Supreme Court published its decision affirming a ruling of the Federal Circuit Court that the genus claims of Amgen’s Repatha® patents were invalid for lack of enablement.

Since 2014, there have been numerous battles between Sanofi, Regeneron and Amgen in relation to the PCSK9 inhibitors in courts and patent offices around the world.  For example:

The settlement is expected to result in the withdrawal by Sanofi, Regeneron and Amgen of various oppositions to patent applications in the European Patent Office and any appeals and proceedings which remain pending in relation to Repatha® and Praluent®.

Celltrion Launches IV Formulation of Biosimilar Infliximab in Europe

On 11 March 2026, Celltrion announced the European launch of its Remsima® IV liquid formulation, biosimilar to Janssen’s Remicade® (infliximab).  This follows the November 2025 approval of Remsima® IV liquid formulation by the European Commission for the treatment of rheumatoid arthritis, adult and paediatric Crohn’s disease and ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

The company has completed patent registrations in most European countries including the UK, Germany and France.  Celltrion has secured national tenders in Denmark and Norway for the Remsima® IV liquid formulation, with sales expected to commence in Norway immediately following the contract award.

The launch of the IV liquid formulation of infliximab aligns with Celltrion’s broader strategy of focusing on formulation-based differentiation announced earlier this year.  This launch completes Celltrion’s full line up of infliximab products, which includes the world’s first subcutaneous infliximab solution product and an IV powder formulation.

Remsima® IV powder formulation was first approved in Europe in 2013 and launched across major European countries in early 2015.  The subcutaneous formulation, Remsima® SC, received European approval in 2019 and was launched in the EU in 2020.  In February 2024, Celltrion launched Remsima® SC in the US under the brand name Zymfentra®.

Several other infliximab biosimilars have been approved around the world, including Hospira/Pfizer/Celltrion’s Inflectra® in the EU, Canada, New Zealand and USA; Samsung Bioepis’s Flixabi® in the EU and Renflexis® in Australia, New Zealand and the USA; Pfizer’s Ixifi® in Australia, New Zealand and the USA; Biocad’s BCD-055 in Russia; Sandoz’s Zessly® in the EU; and Amgen’s Avsola® in the USA.

Pearce IP BioBlast® for the week ending 6 March 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 6 March 2026 are set out below:


Bevacizumab

On 5 March 2026, Outlook Therapeutics provided an update on ONS-5010/Lytenava™, ophthalmic biosimilar to Roche/Genentech’s Avastin® (bevacizumab-vikg), following… Read more here.

Elasomeran

On 3 March 2026, Moderna entered into a settlement with Arbutus Biopharma and Genevant Sciences to resolve the global COVID patent litigation, including the lengthy dispute… Read more here.

Emicizumab

On 4 March 2026, CSPC Pharmaceutical Group announced that it has received approval from China’s National Medical Products Administration (NMPA) to begin clinical trials of… Read more here.

Golimumab

On 3 March 2026, Janssen Biotech Inc and Janssen Sciences Ireland UC filed proceedings against  Bio-Thera Solutions and Accord BioPharma in the US District Court for… Read more here.

Pertuzumab

On 27 February 2026, Genentech filed a complaint at the US International Trade Commission (ITC) alleging that Biocon’s importation of its pertuzumab biosimilar, BMAB… Read more here.

BioPharma Deals

On 26 February 2026, Celltrion reported that it plans to expand its biosimilar lineup to 18 products by 2030 with seven candidates that have either entered clinical development… Read more here.

 

About Pearce IP

Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renowned for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand.  Paul appears in cases before the New Zealand Court of Appeal and High Court of New Zealand, as well as the New Zealand Intellectual Property Office and IP Australia

Paul is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment. Paul is recommended for litigation in the IAM Patent 1000, rated for enforcement and litigation in the WTR1000, ranked for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.

Maliha Hoque

Maliha Hoque

Paralegal

Maliha is a Paralegal and contributing author to Pearce IP’s flagship circulars BioBlast® and BioGxPulse®.  She is currently completing her Juris Doctor at the University of Sydney.  With a background in medical science, finance and risk consulting, and an inquisitive mind, Maliha loves leaving ‘no stone unturned’ when investigating IP/legal ‘challenges’.  Maliha is interested in the intersection of law and science, and digital transformation.  She gets excited about using her science, business management, and legal skills and experience to support Pearce IP’s lawyers, attorneys and clients.

Roche Sues Biocad in Russia for Patent Infringement Regarding Biosimilar Pertuzumab

On 10 March 2026, The Pharma Letter reported that Roche subsidiary, Genentech, had begun legal proceedings before the Moscow Arbitration Court alleging patent infringement by Biocad’s biosimilar to Perjeta® (pertuzumab), Pertuvia™.  Pertuvia™ was approved for sale in Russia in May 2025.

This Russian action comes shortly after Genentech commenced ITC proceedings in the US against Biocon’s pertuzumab biosimilar BMAB 1500 in February this year.

Roche and Genentech recently settled parallel BPCIA (US) proceedings against Shanghai Henlius and Organon relating to their pertuzumab biosimilar, Poherdy®.  Poherdy® was approved by the FDA in November 2025 and received a positive CHMP opinion in early 2026.

Court action by Roche against Zydus regarding its pertuzumab biosimilar, Sigrima®, have been running since the approval of that product in India in 2024.

This multiplicity of pertuzumab-related legal actions reflects Roche’s concern, expressed in mid-2025, that biosimilar competition to Perjeta® would occur sooner than previously expected.

Other pertuzumab biosimilars been approved in Russia for R-Pharm and in India for Intas and Enzene.  Further biosimilars are under development by Sandoz and EirGenix and through an Indo-Brazilian partnership.

Sandoz Announces New Biosimilar Development, Manufacturing and Supply Unit

On 10 March 2026, Sandoz announced the creation of a new global biosimilar development, manufacturing and supply unit, which will come into effect on 1 April 2026.

According to Sandoz, separating the biosimilar and generic development and manufacturing units will allow for more tailored operations, faster decision making and improved alignment.  The announcement noted that biosimilars and generics have different development, manufacturing and supply requirements, making this structural separation beneficial to address the increasingly divergent market dynamics.

Sandoz’s CEO said it was the “start of an unprecedented ‘golden decade’ for patient access, with medicines worth more than USD 650 billion dollars set to lose exclusivity over the next 10 years”.  The restructure will create a strategic opportunity for Sandoz to accelerate full vertical integration of biosimilar development, manufacturing and supply and prepare for major market opportunities.

FDA Issues New Draft Guidance on Biosimilar Development and BPCIA

On 9 March 2026, the FDA issued a new draft guidance on biosimilar development and the BPCIA aimed at reducing upfront research and development timelines and costs for biosimilar developers and lowering the cost of medicines for consumers.  In the new draft guidance, FDA “recommended streamlining unnecessary clinical pharmacokinetic (PK) testing when scientifically justified” stating that “this change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million, and help lower drug costs.

The new draft guidance, New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4) revises and replaces the earlier draft of the guidance (Revision 3) issued in 2021.  It includes revisions to certain Q&As that appeared in a previous version of the final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act.  The new draft is open for public comments until 11 May 2026.

Under the proposed guidelines, clinical data from a comparator product approved outside of the US could be used to demonstrate similarity to the US licensed reference product.  In certain circumstances, this would eliminate the need for an additional three-way PK study, with international clinical data satisfying the FDA.

The new draft guidance removes the previous recommendation for biosimilar developers to conduct at least one clinical PK study directly comparing their proposed biosimilar with the US licensed reference product. Instead, when “scientifically justified”, developers may rely on a non-licensed US comparator product to demonstrate biosimilarity.

The FDA has already begun allowing companies to streamline clinical trial requirements in the US on a case-by-case basis through feedback sessions.  For example, in February 2025, Formycon/Zydus announced the early termination of the Ph 3 trial for biosimilar pembrolizumab after the FDA was satisfied with relying on clinical data from Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program” to support regulatory review.

The FDA also formally withdrew its 2015 final guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, as the document no longer reflects the agency’s current thinking or expectations.

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

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