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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.

New Changes To Divisional Practice In New Zealand

On 2 June 2026 the New Zealand Parliament passed an amendment to the Patents Act 2013 (2013 Act). The 2013 Act replaced the Patents Act 1953. The 2013 Act included transitional provisions that allowed patent applications filed under the 1953 Act, and any divisional patent applications relating to them, to be considered under the earlier and more lenient 1953 Act. With no deadline for filing divisionals, and the ability to indefinitely “daisy-chain” further divisional applications, this has long been perceived as a problem.

The new amendment Act aims to cure that problem by providing that any future 1953 Act divisional applications will only be accepted for grant if the Commissioner of Patents is satisfied on the balance of probabilities standard, that the invention claimed in the application meets the novelty, inventive step and support requirements of the 2013 Act. These criteria will also apply to any opposition, revocation, and re-examination proceedings concerning these divisional applications.

While the amendment signals a clear legislative intent to close the gap between the legacy and modern patent regimes, it received criticism at both draft stage and before a Parliamentary committee, for being made too late to make any practical difference.  This reform was first proposed by the government as long ago as 2016.  At that time, there were still a significant number of 1953 Act applications under examination from which divisionals could be filed.  During the legislative process, the number of these applications has dwindled from around 70, when the draft amendment Bill was published, to 52 when it was passed by Parliament. Of these 52, 27 are owned by the medtech company Resmed, which has been involved in a long-running legal battle with New Zealand company Fisher & Paykel Healthcare.

The Amendment Act will come into force once it receives Royal assent, leaving a window of perhaps a few days from now for any last-minute divisionals to be filed for examination under the 1953 Act standard.  Those keeping a watch on any 1953 Act applications ought to be aware that any divisionals filed after that Assent is given will be examined under the higher modern standard.  Oppositions to these may have a higher chance of success, compared to their parent applications, as they will be considered under that same higher standard.

Updates on the Bill and its passing into law can be viewed here

If you would like tailored advice on any of the developments covered, our team would be pleased to assist. Contact info@pearceIP.law.


 

About Pearce IP

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

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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.

 

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.

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.

Health Canada Accepts Kashiv’s Omalizumab Biosimilar Application

On 4 June 2026, Kashiv BioSciences announced that Health Canada has accepted for review the market authorisation application (MAA) for ADL-018, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018 (also referred to as AVT23) in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.

The Canadian filing follows a series of regulatory advances for ADL-018.  Marketing applications for ADL-018 were accepted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in March 2025 and by the European Medicines Agency (EMA) in October 2025.

Beyond Canada, Kashiv has agreements for the commercialisation of ADL-018 with Brazilian pharmaceutical company, CRISTÁLIA, for the Latin American market (11 August 2025) and MS Pharma for MENA markets (August 2025).

The only omalizumab biosimilar currently approved in Canada, and anywhere else in the world, is Celltrion’s Omlyclo®.  Omlyclo® was approved in Canada in 75mg and 150mg formulations in December 2024 and in 300mg PFS and autoinjector presentations in January 2026.

Omlyclo® has also been approved in: the EU (May 2024 and November 2025 (300mg)); Korea (June 2024 (PFS), December 2025 (autoinjector), 300mg formulation launched 30 March 2026)); Australia (November 2024); the US (March 2025 (75 mg/0.5ml and 150 mg/ml PFS) and December 2025 (300mg)); New Zealand (April 2025); and Japan (March 2026).  Celltrion commenced its European rollout of Omlyclo® in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.

Omalizumab biosimilars are also in development by at least CuraTeQ (Ph 3 study results announced April 2026) and Teva (acceptance for review of biosimilar omalizumab applications in US and EU announced March 2026).

BioImmunity Seeks Approval of Biosimilar Canakinumab in Russia

On 4 June 2026, GxP News reported that Belarusian company, BioImmunity LLC, has obtained registration in Belarus of its biosimilar to Novartis’ Ilaris® (canakinumab) and is seeking approval in Russia.  If registered, this will become the second canakinumab biosimilar approved in Russia after Generium’s Limiris™ (September 2025).

There have not been any reports of canakinumab biosimilars approved elsewhere.  However, in May 2025, Alvotech and Advanz expanded their partnership to include the development and commercialisation of a canakinumab biosimilar (AVT48) in Europe.

Alvotech Resubmits US BLAs for Aflibercept & Golimumab Biosimilars

On 4 June 2026, Alvotech announced that it has resubmitted to the FDA its Biologics License Applications for AVT05 (golimumab), biosimilar to Janssen’s Simponi® and Simponi Aria®, and AVT06 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg.  Alvotech expects the FDA to conduct a 6-month review of the resubmitted BLAs, in line with applicable regulatory timelines.  Both AVT05 and AVT06 will be commercialised in the US by Teva.

The BLAs were resubmitted following completion of an FDA “routine cGMP surveillance inspection” of Alvotech’s Reykjavik manufacturing facility and the provision by Alvotech of responses to observations raised as a result of that inspection.  Alvotech received Complete Response Letters from the FDA for its golimumab, aflibercept, and denosumab (AVT03) biosimilar BLAs in November 2025, December 2025 and January 2026, respectively, and subsequently undertook a “remediation project”.

Alvotech’s BLA for AVT05 was first accepted for review by the FDA in January 2025.  In September 2025, AVT05 was the first golimumab biosimilar to be approved worldwide, with its approval in Japan as Gobivaz®.  Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma.  Accord BioPharma’s Immgolis™ and Immgolis Intri™ were the first golimumab biosimilars approved in the US in May 2026, although their launch date is uncertain given ongoing BPCIA litigation commenced by Janssen against Accord/Bio-Thera in March 2026.

AVT06 (aflibercept, 2mg) has a Q4/2026 US launch date (subject to FDA approval) under a settlement agreement between Alvotech and Regeneron/Bayer.  AVT06 has already been launched in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®).  The only biosimilar aflibercept currently on the market in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  There are a number of approved aflibercept biosimilars, some of which have scheduled H2 2026 launch dates as a result of litigation settlements, including Biocon’s Yesafili® (approved May 2024due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024due to launch Q4/2026), and Celltrion’s Eydenzelt® (approved October 2025due to launch Q4/2026).

Dr Reddy’s, Alvotech’s partner in the US for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), is responsible for resubmitting the BLA for that biosimilar.  AVT03 is currently the subject of BPCIA litigation commenced by Amgen in November 2025 alleging infringement of 31 US patents.

Pearce IP BioBlast® for the week ending 29 May 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 29 May 2026 are set out below:


Aflibercept

On 31 May 2026, Samsung Bioepis announced that it has launched Opuviz™/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg, in Europe through direct… Read more here.

Bevacizumab

On 26 May 2026, Outlook Therapeutics announced that the FDA has granted an appeal following the completion of a Formal Dispute Resolution (FDR) process for… Read more here.

Daratumumab

On 26 May 2026, Shanghai Henlius announced that the first patient has been dosed in its phase 1 international multicentre clinical trial of HLX15-SC (daratumumab and… Read more here.

Denosumab

On 29 May 2026, Boan Biotech announced that it has submitted Biologics License Applications (BLAs) to the FDA for two denosumab biosimilars: BA6101 (denosumab 60 mg)… Read more here.

Guselkumab

On 28 May 2026, Johnson & Johnson (J&J) announced that the FDA has approved a supplemental Biologics License Application (sBLA) to update the Tremfya® (guselkumab)… Read more here.

Natalizumab

On 27 May 2026, Fierce Pharma reported that Italy’s competition regulator (AGCM) has commenced an investigation into Biogen’s alleged abuse of its dominant position in the… Read more here.

Pertuzumab

On 29 May 2026, Shanghai Henlius announced China’s National Medical Products Administration (NMPA) has approved its pertuzumab (HLX11/Hanbeiyou®, marketed as… Read more here.

Secukinumab

On 1 June 2026, Celltrion announced that it has filed an application with Health Canada for marketing authorisation of CT-P55 (secukinumab), biosimilar to Novartis’ Cosentyx®… Read more here.

Trastuzumab

On 28 May 2026, The Seoul Economic Daily reported that Celltrion has filed an application with the Korean Ministry of Food and Drug Safety for approval of Herzuma® SC/CT-P6 SC… Read more here.

About Pearce IP

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

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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 CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in LawExecutive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. 

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

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.

FDA Approves Lupin’s Biosimilar Ranibizumab & Accepts Xbrane’s Resubmitted Ranibizumab BLA

On 2 June 2026, the FDA approved Lupin’s Ranluspec® (ranibiziumab-hkdz) as an interchangeable biosimilar of Genentech’s Lucentis®.  Ranluspec® is approved in both vial and pre-filled syringe presentations for the treatment of nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema, diabetic retinopathy, and myopic choroidal neovascularization.

The following day, on 3 June 2026, Xbrane announced that the FDA accepted its biosimilar ranibizumab BLA, which has been given a Biosimilar User Fee Act (BsUFA) action date of 29 October 2026.  The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with Valorum Biologics, which will be responsible for commercialising the product in the US under the name Lucamzi™.

Xbrane resubmitted its BLA in April 2026 following an FDA Complete Response Letter (CRL) received in October 2025.  This was the second CRL issued in relation to Xbrane’s ranibizumab BLA following a first CRL in April 2024 identifying issues relating to (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites.

The first ranibizumab biosimilar approved in the US was Samsung Bioepis’ Byooviz® (September 2021), followed by Sandoz’s Cimerli® (August 2022rights acquired by Sandoz from Coherus in March 2024), and Formycon’s Nufymco® (December 2025).

Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®, and was launched in the EU in April 2023.  Lupin’s Ranluspec® was approved in the EU in February 2026, where it is being commercialised by Sandoz under an August 2025 agreement.

Daewoong and Chime Biologics Partner on Biosimilar Dupilumab

On 2 June 2026, South Korean-headquartered Daewoong Pharmaceutical and Chinese-based global biologics contract development and manufacturing organisation (CDMO), Chime Biologics, announced that they have entered a strategic partnership agreement for the development, manufacture and commercialisation of a biosimilar of Sanofi/Regeneron’s Dupixent® (dupilumab).

Under the agreement, Chime will support the development and manufacture of Daewoong’s dupilumab biosimilar, while both companies will collaborate on commercialisation.

Although Daewoong has previously partnered on biosimilars in the Korean market (for example, promoting and launching Celltrion’s denosumab biosimilars in Korea), the dupilumab agreement with Chime is intended to be the foundation of its biologics expansion strategy, building the Dupixent® biosimilar into a global product.

Biosimilar dupilumab is under development by at least Samsung BioepisBio-Thera Solutions and Costa Rican-based SteinCaresAlvotech and Advanz, Binnopharm and Mabwell and Amneal.  In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.  In January 2026, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab).

Celltrion Files Canadian Application for Biosimilar Secukinumab

On 1 June 2026, Celltrion announced that it has filed an application with Health Canada for marketing authorisation of CT-P55 (secukinumab), biosimilar to Novartis’ Cosentyx®, seeking all approved reference indications.  Celltrion is also planning regulatory filings for CT-P55 in the US, Europe and Korea.

According to Celltrion, its first biosimilar secukinumab application was filed in Canada on the basis that it is a “pro-biosimilar nation” and pursues “policies to promote the introduction of biosimilars and [improve] its regulatory environment”.

The Canadian application is based on Celltrion’s Phase 1 trials, results of which were presented in September 2025.  In February 2026, Celltrion received approval from the European Medicines Agency to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55.

Secukinumab biosimilars are under development by at least 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).

New Indication Alert: BMS’ Nivolumab Combo EU-Approved for cHL

On 1 June 2026, BMS announced that the European Commission has approved Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adults and adolescents over 12 years of age with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL).  The Opdivo® plus AVD combination is the first immunotherapy-based regimen available in the EU for newly diagnosed advanced cHL.

This cHL indication was recommended by the CHMP in April 2026 and approved by the FDA in March 2026.  BMS also added another cHL indication to its European registration in March 2026, with approval for nivolumab in combination with brentuximab vedotin for the treatment of relapsed or refractory cHL after one prior line of therapy.

A number of nivolumab biosimilars are under development including Sandoz’s JPB898Xbrane/Intas’ Xdivane™Amgen’s ABP 206Reliance Life Sciences’ RLS-NivolumabEnzene’s candidateBoan Biotech’s BA1104NeuClone’s candidate and Zydus’ ZRCr-4276.

Samsung Bioepis Launches Biosimilar Aflibercept in Europe

On 31 May 2026, Samsung Bioepis announced that it has launched Opuviz™/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg, in Europe through direct sales.

The launch follows a settlement agreement between Samsung Bioepis and Regeneron/Bayer in relation to the aflibercept biosimilar announced in January 2026.  Under the agreement, Samsung Bioepis was permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement from May 2026 (excluding Korea where it had already been on the market as Afilivu® since 2024).  Samsung Bioepis has a separate settlement agreement with Regeneron/Bayer for North America, permitting launch of Opuviz™ in the US from January 2027.

Opuviz™ was the third aflibercept biosimilar to be approved in the EU in November 2024 and has been approved elsewhere, including the UK (April 2025), the US (May 2024), Korea (as Afilivu®) (February 2024) and Australia (September 2025).

The European launch of Opuviz™ comes two weeks after Formycon/Klinge launched their aflibercept biosimilar, FYB203, in key European markets.  Aflibercept biosimilars have also been launched in Europe including by Sandoz (Afqlir® launched in UK in November 2025) and Celltrion (Eydenzelt® launched in UK and EU in December 2025).  Settlement agreements between Regeneron/Bayer and other companies permit further 2026 EU biosimilar aflibercept launches, including for Alvotech and Biocon.

Pearce IP and 5 Leaders Ranked in IAM Patent 1000 2026 for AU and NZ Patent Prosecution and Litigation

Pearce IP and five of its leaders have been recognised in the IAM Patent 1000 for 2026, with rankings across Australia and New Zealand for patent litigation and patent prosecution.

2026 marks the sixth consecutive year of Pearce IP Australia being ranked in the IAM Patent 1000 – one of only 51 law firms recognised this year – and our second consecutive year achieving Silver rankings for both Prosecution and Litigation.

Pearce IP New Zealand has been ranked for Prosecution by IAM Patent 1000 every year since the office opened in New Zealand in 2024 and is one of only 17 firms listed this year.

In addition to Pearce IP’s firm-wide rankings, several of the firm’s key leaders received individual recognition, part of only 199 individuals listed in Australia and 53 in New Zealand:

Naomi Pearce | Founder & CEO, Executive Lawyer, Patent and Trade Mark Attorney
Gold (AU) Litigation; Gold (AU) Prosecution.

“…dual qualifications as an executive lawyer and patent attorney shape Pearce IP’s integrated approach to life sciences IP.  With a background in molecular biology and substantial experience in both private practice and in‑house environments, she is the strategic driver behind many of the firm’s most complex patent programmes.  Pearce’s practice spans early‑stage innovation capture, freedom‑to‑operate assessment, and sophisticated market‑entry strategy for advanced therapeutics, positioning her as the central architect of the firm’s cross‑border patent planning.” – IAM Patent 1000

Helen Macpherson | Executive Lawyer & Head of Litigation AU
Silver (AU) Litigation; Silver (AU) Transactions.

“…scientific grounding in biochemistry and molecular biology enables her to navigate disputes involving tight intersections of law and technical subject matter.  Her role within the team ensures continuity from early strategic advice through to the demands of active enforcement, amendments and validity analysis, creating a strong bridge between legal theory and courtroom execution.” – IAM Patent 1000

Paul Johns | Executive Lawyer, Trade Mark Attorney & Head of Litigation NZ
Recommended (NZ) Litigation.

“…brings more than 25 years of experience to the practice, having previously worked at large multinational firms, and combines strong technical and legal acumen in IP litigation with a scientific background in genetics and microbiology.” – IAM Patent 1000

Jacinta Flattery-O’Brien | Special Counsel, Patent Attorney
Silver (AU) Prosecution.

“With over 20 years’ experience and a doctorate in a biotech discipline, Flattery-O’Brien leads prosecution work for biotechnology, pharmaceutical and biopharmaceutical portfolios.  Her practised hand in drafting, claim development and multi‑jurisdictional coordination ensures that the firm’s strategic advice is matched by technically precise and commercially relevant protection.” – IAM Patent 1000

Chantal Savage | Special Counsel, Lawyer
Next Generation Leader (AU).

“Australian and UK experience adds further depth in multi‑jurisdictional patent disputes.  Savage’s work spans pharmaceuticals, biopharmaceuticals, gene‑editing, medical devices and a range of engineering‑based technologies.” – IAM Patent 1000

IAM 1000 comments:

“Pearce IP has established itself as a go‑to outfit for life sciences mandates across Australia and New Zealand.  Combining technical depth with seasoned legal insight, the firm delivers integrated prosecution and advisory services for innovators and companies operating in pharmaceuticals, biopharmaceuticals, biotechnology, ag‑tech, food‑tech and med‑tech.  Its practitioners bring substantial scientific grounding, enabling the group to navigate complex portfolios, product lifecycles and cross‑border patent strategies with ease.  The team is also recognised for its strong collaborative culture and for fielding one of the region’s most experienced concentrations of life sciences specialists.”


 

About Pearce IP

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

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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.

 

Shanghai Henlius’ Biosimilar Pertuzumab Approved in China

On 29 May 2026, Shanghai Henlius announced China’s National Medical Products Administration (NMPA) has approved its pertuzumab (HLX11/Hanbeiyou®, marketed as Poherdy® in the US and Europe), biosimilar to Roche’s Perjeta® (pertuzumab).  Hanbeiyou® is approved for all Perjeta® indications.

HLX11/Poherdy® was the first pertuzumab biosimilar approved in the US (November 2025) and EU (April 2026).  In the US, a BPCIA patent challenge by Genentech/Roche against Henlius/Organon regarding Poherdy® was settled in January 2026 on confidential terms, with no details of any planned US launch of Poherdy® being disclosed to date.

Organon has exclusive global commercialisation rights to HLX11, “except for China; including Hong Kong, Macau and Taiwan”, under a June 2022 deal.

Pertuzumab biosimilars have been approved in India, including Intas’ biosimilar (December 2024, subject to submission of further studies), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved.  Pertuzumab biosimilars are also under development by Sandoz and EirGenix.  In February 2026, Genentech commenced US ITC proceedings against Biocon regarding its pertuzumab biosimilar, BMAB 1500.

Replimune Makes Third Submission to FDA for Vusolimogene Oderparepvec Plus Nivolumab

On 29 May 2026, Replimune announced that, following collaborative communications with the FDA, the company and the FDA have aligned on a path for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.  Replimune says it will resubmit the RP1 BLA in the coming days.  The FDA has indicated it will treat the BLA resubmission as an urgent matter upon receipt and will prioritise its review in recognition of the significant unmet need for patients in the advanced melanoma community.

This announcement has caused some recovery in Replimune’s share price following the negative impact of the FDA’s April 2026 rejection of the first resubmission of the BLA, which in turn followed the rejection of the original November 2024 application.

Other reports record that Replimune met with the White House and that the FDA has been “pushed” to reexamine the RP1 BLA.

Celltrion Submits Korean Application for Biosimilar Trastuzumab SC

On 28 May 2026, The Seoul Economic Daily reported that Celltrion has filed an application with the Korean Ministry of Food and Drug Safety for approval of Herzuma® SC/CT-P6 SC, biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™).  The subcutaneous (SC) application was submitted for all Herceptin® SC indications, including the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

This follows Celltrion’s announcement on 30 April 2026 that it had submitted an application to the European Medicines Agency (EMA) for Herzuma® SC.  The timing of these applications aligns with Celltrion’s December 2025 announcement that it had been conducting clinical trials for Herzuma® SC (CT-P6 SC) since February 2025 and planned to submit applications for approval of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.  According to Celltrion, it plans to proceed with regulatory submissions for Herzuma® SC in other major countries.

There are currently no biosimilar SC formulations of trastuzumab on the market and Celltrion considers it is well-placed to enjoy a “first mover” advantage.  In January 2026, Biocon Biologics announced that it had added a trastuzumab/hyaluronidase product, referencing Roche’s Herceptin® SC/Herceptin Hylecta™, to its biosimilar development pipeline.

FDA Approves Label Expansion for Tremfya® (Guselkumab) to Include Inhibition of Structural Joint Damage in Psoriatic Arthritis

On 28 May 2026, Johnson & Johnson (J&J) announced that the FDA has approved a supplemental Biologics License Application (sBLA) to update the Tremfya® (guselkumab) label to include data demonstrating that the treatment inhibits the progression of structural joint damage in adults with active psoriatic arthritis (PsA).  The label update positions Tremfya® as the only IL-23 inhibitor with demonstrated structural inhibition in its label, offering patients with active PsA a first-line treatment option that provides both symptom control and protection against irreversible joint damage.

Tremfya® was first approved in the US for moderate-to-severe plaque psoriasis (PsO) in July 2017.  Since then, its approved indications have been significantly expanded: the FDA approved Tremfya® for moderately to severely active ulcerative colitis (UC) in September 2024, followed by approval of a subcutaneous induction regimen for UC in September 2025, and approval for moderately to severely active Crohn’s disease in March 2025.  In September 2025, the FDA also extended Tremfya®’s PsO and PsA approvals to children aged six and older weighing at least 40 kg.

No guselkumab biosimilars have been approved in any major market, and biosimilar development of guselkumab appears to be at early stages globally.  In September 2025, Polpharma Biologics and MS Pharma entered into a licensing agreement for the commercialisation of PB019 (biosimilar guselkumab) in the Middle East and North Africa (MENA) region.  Alvotech has a proposed guselkumab biosimilar in development (partnered with Advanz Pharma for commercialisation in the EU, UK and Switzerland), and Samsung Bioepis announced in January 2026 that it has biosimilar guselkumab in development.

 

Pearce IP Ranked in 2027 ‘Best Law Firms Australia’ for Life Sciences & Intellectual Property

We are delighted to share that Pearce IP has been ranked in the 2027 edition of Best Law Firms – Australia in the categories of Life Sciences and Intellectual Property.

Published by Best Lawyers and underpinned by a rigorous methodology, the Best Law Firms – Australia is in its third edition.  This is the second time Pearce IP has been recognised, with rankings in both Life Sciences and IP.

With the Sydney region category spanning a broad footprint – from the Sydney CBD and Greater Sydney through to the Hunter region, Southern Highlands, Central West NSW, and the Illawarra – these rankings recognise excellence across one of Australia’s most commercially significant and highly competitive legal markets.

Being ranked among the top 3% of law firms nationally is a significant achievement and reflects our consistent focus on excellence, as well as our commitment to delivering meaningful results for our clients.

Naomi Pearce, founder and CEO of Pearce IP says:

“I never cease to be impressed by the calibre and commitment of the Pearce IP team. It is both a pleasure and a privilege to see the firm again recognised for its legal/IP sophistication and industry specialisation. This achievement reflects the strength of our independent, values-driven approach and our unwavering focus on delivering exceptional outcomes for our clients.”

Earlier this year, Helen Macpherson was also recognised in Best Lawyers Australia 2027 for Intellectual Property Law and Life Sciences, continuing her unbroken run of listings every year since 2017.


 

About Pearce IP

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

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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.

 

Italy’s Competition Regulator Investigates Biogen’s Alleged Anti-Competitive Conduct in MS Market Due to Stratify Natalizumab Test

On 27 May 2026, Fierce Pharma reported that Italy’s competition regulator (AGCM) has commenced an investigation into Biogen’s alleged abuse of its dominant position in the multiple sclerosis drug market.

Biogen markets Tysabri® (natalizumab) for the treatment of multiple sclerosis.  Treatment with natalizumab can cause a rare but serious side effect, which means that patients are required to undergo a specific test (the ‘anti-JCV test’) before and during treatment with natalizumab.  AGCM is concerned that Biogen is using its anti-JCV Stratify test to exclude or limit competition from Sandoz by tying the use of the test to the purchase of Tysabri®, and refusing to make it commercially available to patients treated with Sandoz’s natalizumab product, Tyruko®.

Tyruko® was developed by Polpharma Biologics pursuant to a global commercialisation agreement with Sandoz reached in 2019.  As part of the agreement, Sandoz has exclusive rights to commercialise and distribute the product in all markets.  Tyruko® is approved in multiple markets, including the US (August 2023), Europe (September 2023) and Australia (April 2025).

Pearce IP BioBlast® for the week ending 22 May 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 22 May 2026 are set out below:


Aflibercept

On 19 May 2026, Formycon and Klinge Biopharma announced that the European launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), commenced… Read more here.

Denosumab

On 21 May 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) approved an expanded set of indications for Maiweijian™, biosimilar to… Read more here.

Pembrolizumab

On 20 May 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved MSD’s Keytruda SC™ (pembrolizumab and… Read more here.

Ranibizumab, Liraglutide

On 22 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its May 2026 meeting, including… Read more here.

Semaglutide

On 20 May 2026, The Economics Times reported that Zydus Lifesciences plans to commercialise its generic semaglutide formulation across more than 20 markets over the… Read more here.
On 22 and 23 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two new formulations of… Read more here.

Ustekinumab

On 20 May 2026, Samsung Bioepis announced that it has launched SB17, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan through its local marketing partner… Read more here.

 

Biopharma Deals

On 22 May 2026, Polpharma Biologics and Tuteur announced that they have entered into an exclusive licensing agreement for the commercialisation of an unnamed biosimilar… Read more here.

About Pearce IP

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

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

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 CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.

Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice.  Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in LawExecutive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”.  Ranked in Chambers Asia Pacific, Chambers Global,  IAM Patent 1000IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. 

Pearce IP is the premier life sciences focussed firm in ANZ.  Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees).  In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.

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.

Boan Biotech Files US BLAs for Denosumab Biosimilars and Receives Approval for New Indication in China

On 29 May 2026, Boan Biotech announced that it has submitted Biologics License Applications (BLAs) to the FDA for two denosumab biosimilars: BA6101 (denosumab 60 mg) and BA1102 (denosumab 120 mg), biosimilars to Amgen’s Prolia® and Xgeva® respectively.  The BLAs seek approval for all indications of the reference products.

Days earlier, on 26 May 2026, Boan Biotech announced that China’s National Medical Products Administration (NMPA) approved its supplemental application for Boluojia® (BA11021) (denosumab injection 120 mg), biosimilar to Xgeva®, for the treatment of patients with bone metastases from solid tumours or multiple myeloma, to delay or reduce the risk of skeletal-related events (SREs), which include pathological fractures, spinal cord compression, and bone-directed radiation or surgery.  Boluojia® was first approved in China in May 2024 for the treatment of giant cell tumour of bone.

Boan Biotech’s Boyoubei® (BA6101) was approved in China in November 2022 and in Bolivia in January 2026.  In November 2025, Boan Biologics’ MAAs for BA6101 and BA1102 were accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA).  According to Boan Biotech, regulatory submissions for its denosumab biosimilars are also planned for Europe and Japan, among other regions.

Denosumab biosimilars have been approved and launched around the world by a variety of sponsors.  In the US, this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025Ospomyv™ included on US formularies from 1 April 2026), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025launched October 2025), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025launched January 2026), Accord’s Osvyrti® and Jubereq® (approved November 2025) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

First Patient Dosed in Phase I Trial for Shanghai Henlius’ Biosimilar Daratumumab SC

On 26 May 2026, Shanghai Henlius announced that the first patient has been dosed in its phase 1 international multicentre clinical trial of HLX15-SC (daratumumab and hyaluronidase-fihj), biosimilar to J&J’s Darzalex Faspro®, for the treatment of multiple myeloma.

Shanghai Henlius’ Investigational New Drug (IND) application for the phase 1 clinical trial of HLX15-SC was approved by the FDA in February 2026, shortly after the trial was approved in China.

Henlius is also developing an IV form of HLX15, having completed a successful Phase 1 clinical trial of HLX15-IV against US, EU and CN sourced Darzalex® (daratumumab) in June 2024.

Both SC and IV forms of HLX15 will be commercialised by Dr Reddy’s in Europe and the US under the terms of a licence agreement announced in February 2025.

The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025 for Daratumia®.  Daratumumab biosimilars are under development, including by CSPC Pharmaceutical Group, which obtained approval from the NMPA in December 2025 to conduct clinical trials in China of its Daratumumab Injection, and Celltrion, whose Phase 3 clinical trial plan for CT-P44 (daratumumab) was approved in Europe in September 2025.

Outlook Therapeutics Wins Appeal of FDA’s CRL for Ophthalmic Bevacizumab, Plans to Resubmit BLA in June 2026

On 26 May 2026, Outlook Therapeutics announced that the FDA has granted an appeal following the completion of a Formal Dispute Resolution (FDR) process for ONS-5010/Lytenava™ (bevacizumab-vikg) for wet AMD.  The FDR process is an appeal mechanism that permits a sponsor to obtain formal review of any FDA decision by raising the matter with the supervisor of the employee who made the decision.

In December 2025, the FDA issued a Complete Response Letter (CRL) for the second resubmission of ONS-5010/Lytenava™, recommending that additional confirmatory evidence be provided to support Outlook’s application, though it did not clarify what type of evidence would be acceptable.  Outlook subsequently attended a Type A meeting with the FDA in March 2026 to discuss the CRL and then submitted its Formal Dispute Resolution Request in April 2026.

In its appeal decision, the FDA concluded that substantial evidence of effectiveness has been established for Lytenava™ for the treatment of wet AMD, despite the earlier CRL.  The decision directs the FDA’s Division of Ophthalmology (Division) and Office of Specialty Medicine (OSM) to work with Outlook Therapeutics to reach agreement on final labelling.

Outlook Therapeutics expects to resubmit the BLA for ONS-5010/Lytenava™ in June 2026.  If approved, ONS-5010/Lytenava™ would be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA.

Lytenava™ was approved in the EU in May 2024 and in the UK in July 2024.  It was launched in the UK and Germany in June 2025.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

Amneal & Kashiv Challenge US Omalizumab Patent

On 26 May 2026, Amneal Pharmaceuticals and Kashiv Biosciences filed a petition with the Patent Trial and Appeal Board for inter partes review of Genentech/Novartis’ US Patent No. 12,030,959.  The patent relates to methods for treating food allergies in paediatric patients by administering omalizumab.

Amneal and Kashiv argue that the claims of the US959 patent are invalid because they lack novelty and/or are obvious, including in light of articles disclosing the results of phase 1 or 2 clinical trials of omalizumab in patients with food allergies.

Amneal submitted a Biologics Licence Application (BLA) to the FDA for its omalizumab (ADL-018), biosimilar to Genentech/Novartis’ Xolair®, in September 2025.  ADL-018 was developed by Kashiv, with Amneal holding exclusive US commercialisation rights for the product, under a July 2024 licensing agreement.

Kashiv has also entered into agreements for the commercialisation of ADL-018 in other regions, including with CRISTÁLIA for LATAM markets (August 2025), MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Celltrion’s Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world.  Omlyclo® was approved in the US in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and in December 2025  (300mg formulation).  Celltrion commenced its European rollout of Omlyclo® with the launch of the product in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.

Omalizumab biosimilars are in development, including by Teva (acceptance of regulatory applications for review by the FDA and EMA announced March 2026) and CuraTeQ (phase 3 biosimilar omalizumab trial completed April 2026).

Polpharma Biologics Inks Exclusive Licensing Deal with Tuteur for Autoimmune Disease Biosimilar in LATAM

On 22 May 2026, Polpharma Biologics and Tuteur announced that they have entered into an exclusive licensing agreement for the commercialisation of an unnamed biosimilar for the treatment of an autoimmune disease in Latin America, excluding Brazil.

Under the agreement, Swiss-based Polpharma Biologics will be responsible for the development, manufacture and supply of the product, while Argentina-based Tuteur will be responsible for the commercialisation, marketing and distribution across Latin America, excluding Brazil.

The unnamed biosimilar is currently in development, with the companies anticipating a regulatory submission to be filed within the next three years.

In December 2025, Polpharma Biologics entered into an exclusive licensing agreement with Libbs Farmacêutica, for the commercialisation of an unnamed biosimilar for autoimmune diseases in Brazil.  This deal followed a licensing agreement between Polpharma and MS Pharma in September 2025 for the commercialisation in the MENA region of biosimilars to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®).  In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).

Novo Nordisk Secures CHMP Backing for Oral & High-Dose Semaglutide

On 22 and 23 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two new formulations of Novo Nordisk’s semaglutide:

The Wegovy® pill is the first oral GLP-1 treatment recommended for approval by CHMP for weight management in the EU. It follows the first-in-world US approval of the oral formulation by the FDA on 23 December 2025 and US launch of the Wegovy® pill on 5 January 2026.  Eli Lilly’s Foundayo™ (orforglipron), the only other oral GLP-1 receptor therapy for weight loss, received US FDA approval on 1 April 2026 and became available to patients on 6 April 2026.

High dose Wegovy® expands the dosing options available in Europe, with Wegovy® currently available only as once-weekly treatment with three separate 2.4 mg injections administered one after each other.  Novo Nordisk expects to launch Wegovy® 7.2 mg in a single-dose pen in Q3 2026 in Europe.  Wegovy® 7.2 mg is already available in the US under the brand name Wegovy® HD.

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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