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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 31 July 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 31 July 2026 are set out below:


Insulin Aspart

On 30 July 2026, On 30 July 2026, Chicago-headquartered Meitheal Pharmaceuticals announced that the FDA has approved Garzulys™…. Read more here.

Nivolumab

On 29 July 2026, the EPO published the Board of Appeal’s decision of 6 May 2026 upholding the Opposition Division’s 13 March 2024 revocation… Read more here.

Pertuzumab

On 26 July 2026, Roche and Genentech commenced BPCIA proceedings in the US District Court in New Jersey against Biocon in relation to Biocon’s Bmab 1500… Read more here.

Rituximab

On 1 August 2026, the Economic Times reported that the FDA has approved Dr Reddy’s biosimilar to Genentech’s Rituxan® (rituximab). The product will be… Read more here.

Semaglutide

On 29 July 2026, Sandoz announced that Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has approved Owozy® (semaglutide), a generic version… Read more here.


Trastuzumab deruxtecan

On 28 July 2026, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for… Read more here.

Ustekinumab

On 29 July 2026, Biocon announced that it has received Notice of Compliance (NOC) approval from Health Canada for ustekinumab (Yesintek®)… Read more here.

Vedolizumab

On 31 July 2026, Polpharma Biologics and Fresenius Kabi announced that Polpharma’s Biologics License Application (BLA) and Marketing Authorisation… Read more here.
 
On 31 July 2026, judgment was published in relation to procedural matters in proceedings commenced earlier this year in the High Court of… Read more here.

Biopharma News

On 30 July 2026, Seoul Economic Daily reported that Celltrion is partnering with Korean-headquartered G2GBIO to convert antibody drugs to subcutaneous… Read more here.
 
On 29 July 2026, Alvotech announced that the US FDA has closed its inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland with the… 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 & Trade Mark Attorney (Trans Tasman)

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.

Dr Reddy’s Biosimilar to Genentech’s Rituxan® (Rituximab) US-Approved Following 2024 Settlement and FDA CRL

On 1 August 2026, the Economic Times reported that the FDA has approved Dr Reddy’s biosimilar to Genentech’s Rituxan® (rituximab).  The product will be commercialised in the US by Fresenius Kabi.

The FDA approval follows a Complete Response Letter (CRL) issued to Dr Reddy’s by the FDA in April 2024 regarding its biosimilar rituximab BLA.  The CRL related to the results of regulatory inspections at Dr Reddy’s Biologics facility in 2023, as well as “certain aspects pertaining to the BLA”.  Also in 2024, a settlement was reached in relation to patent infringement claims brought in the US District Court for the District of New Jersey by Genentech, Roche and Biogen against Dr Reddy’s and Fresenius Kabi in respect of Dr Reddy’s rituximab.  The terms of the settlement are confidential.

Dr Reddy’s rituximab biosimilar is already commercialised in more than 28 markets, including India (marketed as Reditux®) and Europe (marketed as Ituxredi®), and has also received marketing approval in Switzerland and Canada.

Rituxan® was first approved in the US on 26 November 1997 and was one of the first mAbs to face biosimilar competition.  There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020, interchangeability status announced July 2026), Pfizer’s Ruxience® (launched in January 2020) and Amgen and Allergan’s Riabni™ (approved by the FDA in December 2020).

Fresenius Kabi, Advanz, Accord & Samsung Bioepis in London Court with Takeda/Millennium Over Vedolizumab Biosimilars

On 31 July 2026, judgment was published in relation to procedural matters in proceedings commenced earlier this year in the High Court of England and Wales (Patents Court) by each of Fresenius Kabi, Advanz Pharma, Accord Healthcare and Samsung Bioepis (Biosimilar Claimants) against Millennium Pharmaceuticals, a Takeda subsidiary.  The Biosimilar Claimants are seeking to clear the way for the UK launch of their biosimilar vedolizumab products, referencing Takeda’s Entyvio®.

In each of the proceedings, the Biosimilar Claimant has applied for the revocation of various Millenium patents and/or for non-infringement declarations or Arrow declarations (that a particular product/process was obvious at the relevant priority date).  The patents at issue concern dosing regimens in respect of vedolizumab (EP (UK) 3329965, 3311834 and pending patent applications EP4378484 and EP4438625)) and formulations for vedolizumab (EP (UK) 2704798 and 4403579).

The four proceedings are being heard together and the Biosimilar Claimants have agreed to use their “best endeavours” to align the grounds of invalidity they are relying on by 10 September 2026.  A trial is currently scheduled for April 2027.

The July 2026 judgment primarily concerned a dispute between Advanz and Millenium/Takeda in relation to the confidentiality regime applying to information about Advanz’s IV and SC vedolizumab formulations.  The parties had agreed that only UK lawyers and two in-house personnel should have access to Advanz’s confidential information and that the in-house individuals should be prohibited from being involved in claim drafting prior to the grant of a patent.  Advanz argued that the restriction on claim drafting should also extend to claim amendments or auxiliary requests in foreign proceedings or the European Patent Office for granted patents.  In his July 2026 judgment, Mr Justice Mellor concluded that the extended prohibition sought by Advanz should be imposed.

Advanz is the UK, EU and Swiss commercialisation partner for Alvotech’s intravenous vedolizumab biosimilar, AVT16, under a 2023 licence agreement.  In June 2026, Alvotech announced that its BLA for AVT16 was the first to be accepted for review by the FDA.  Alvotech also has a subcutaneous vedolizumab biosimilar under development, AVT80.

Fresenius Kabi is commercialising Polpharma Biologics’ PB016 (vedolizumab) in the UK, under a global licensing agreement (excluding MENA region) entered in August 2025.  On the same date on which the July 2026 judgment was published, Polpharma/Fresenius announced that the Marketing Authorisation Application for PB016 had been accepted for review by the European Medicines Agency (with the corresponding BLA accepted by the FDA).

Accord Healthcare’s parent company, Intas, received approval to conduct a Phase 1 bioequivalence study for its vedolizumab biosimilar, INTP53, in February 2025.  Samsung Bioepis’ vedolizumab biosimilar will be commercialised (except in certain Asian countries) by Sandoz under a global licence, development and commercialisation agreement announced in March 2026.

Polpharma/Fresenius Kabi’s Biosimilar Vedolizumab Accepted for Review in US & EU

On 31 July 2026, Polpharma Biologics and Fresenius Kabi announced that Polpharma’s Biologics License Application (BLA) and Marketing Authorisation Application (MAA) for PB016 (vedolizumab), biosimilar to Takeda’s Entyvio®, have been accepted for review by the FDA and European Medicines Agency (EMA), respectively.  In both regions, PB016 is delivered in a lyophilised vial for intravenous administration and is indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease.

The biosimilar was developed by Polpharma Biologics, and Fresenius Kabi holds the exclusive commercialisation rights (excluding the MENA region) under a global licensing agreement announced in August 2025.  Polpharma entered into a licensing agreement with MS Pharma for commercialisation of PB016 (and other biosimilars) in the MENA region in September 2025.

In February 2024, Polpharma announced that PB016 demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.  A phase 3 trial comparing PB016 to Entyvio® in patients with ulcerative colitis was also undertaken.

The first FDA acceptance of a BLA for a vedolizumab biosimilar was in June 2026, for Alvotech’s AVT16 (lyophilised vial for IV administration).  AVT16 will be commercialised by Teva under a strategic partnership entered in August 2020 and expanded in 2023.  Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), with positive results from a PK study for the product announced in February 2026.

Other vedolizumab biosimilars are under development, including by Intas (Indian approval to conduct Phase I bioequivalence study of INTP53 in February 2025) and Samsung Bioepis (in early-stage development, global licence, development and commercialisation agreement (excluding certain Asian countries) entered with Sandoz in March 2026).

Celltrion & G2GBIO Collaborate on High Concentration SC Antibody Drug Development

On 30 July 2026, Seoul Economic Daily reported that Celltrion is partnering with Korean-headquartered G2GBIO to convert antibody drugs to subcutaneous injection formulations.  The companies have signed a strategic memorandum of understanding, including a material transfer agreement, for “ultra-high concentration antibody SC formulation platform technology”.

As part of the collaboration, Celltrion and G2GBIO will evaluate G2GBIO’s InnoBioLAMP platform using Celltrion’s antibody assets and will explore joint development opportunities.  The InnoBioLAMP platform uses microparticle technology to convert intravenous antibody therapies into subcutaneous formulations.

In March 2026, G2GBIO entered into a research collaboration and licence agreement with Samsung Bioepis and its sister company, Epis NexLab, to develop long-acting semaglutide, with an option for Samsung Bioepis to licence another undisclosed G2GBIO asset.

FDA Approves Meitheal’s Garzulys™, Biosimilar to Novo Nordisk’s NovoLog® (Insulin Aspart)

On 30 July 2026, Chicago-headquartered Meitheal Pharmaceuticals announced that the FDA has approved Garzulys™ (insulin aspart-fsan) injection, biosimilar to Novo Nordisk’s NovoLog®.  Garzulys™ is indicated to improve glycaemic control in adult and paediatric patients with diabetes mellitus and is approved for both intravenous and subcutaneous administration.

Garzulys™ was developed by China-based Tonghua Dongbaou Pharmaceutical and companies affiliated with Meitheal.  The Biologics License Application (BLA) is held by Emerge Biosciences.  Meitheal is the US regulatory agent with exclusive US commercialisation rights for Garzulys™ under a 2023 licence agreement with Emerge.

According to Meitheal, the FDA approval of Garzulys™ advances the company’s strategy to expand its established generic injectable business and build a broader portfolio of biologics and branded products.  Meitheal is also commercialising Yusimry™, biosimilar to AbbVie’s Humira® (adalimumab) in the US after the product was divested from Coherus BioSciences to Hong Kong Friend, Meitheal’s parent company, in June 2024.  A high concentration formulation of Yusimry™ is in development.  Meitheal is also partnering with Boan Biotech on denosumab biosimilars, for which a regulatory submission has been lodged.

Sanofi-Aventis’ Merilog™/Merilog™ SoloStar were the first US approved biosimilars to NovoLog® in February 2025.  In July 2025, Biocon Biologics announced that the FDA approved Kirsty™ (insulin aspart-xjhz) as the first and only interchangeable insulin aspart biosimilar.

FDA Closes Inspection of Alvotech’s Icelandic Manufacturing Facility

On 29 July 2026, Alvotech announced that the US FDA has closed its inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland with the inspection classification “Voluntary Action Indicated (VAI)”.  The routine cGMP surveillance inspection was conducted in May 2026.

The VAI classification means objectionable conditions or practices were found during the inspection, however the FDA did not take or recommend any administrative or regulatory action.   Alvotech’s CEO, Lisa Graver, stated that “the actions we have taken have effectively addressed the observations identified”.

Alvotech resubmitted its BLAs for AVT05 (golimumab) and AVT06 (aflibercept) to the FDA in June 2026.  This followed the receipt of Complete Response Letters from the FDA for Alvotech’s golimumab, aflibercept, and denosumab (AVT03) BLAs in November 2025, December 2025 and January 2026, respectively, and a subsequent  “remediation project” undertaken by Alvotech to address the FDA’s comments.

Health Canada Approves Biocon’s Ustekinumab Autoinjector

On 29 July 2026, Biocon announced that it has received Notice of Compliance (NOC) approval from Health Canada for ustekinumab (Yesintek®), biosimilar to Janssen’s Stelara®, in an autoinjector pen format (45 mg/0.05mL and 90 mg/mL).

Yesintek® was first approved in Canada in October 2025 in the following formulations: solution for subcutaneous injection, 45 mg/0.5mL (prefilled syringe and vial) and 90 mg/mL (prefilled syringe); and solution for intravenous infusion, 130 mg/26mL (5 mg/mL).  The product was launched in Canada in the same month.

On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen for Canada, Japan, Europe and the UK.  Yesintek® was approved in the US in early December 2024, and was subsequently launched in February 2025, following a US settlement entered in February 2024.

Other ustekinumab biosimilars approved and launched in Canada to date, include JAMP/Alvotech’s Jamteki® (approved November 2023launched March 2024), Amgen’s Wezlana® (approved December 2023launched March 2024), Celltrion’s Steqeyma® (approved July 2024launched August 2024, with an autoinjector form approved in March 2026), Fresenius’ Otulfi® (approved January 2025launched May 2025), Samsung Bioepis’ Pyzchiva™ (approved August 2024, 2026 launch planned) and Dong-A ST/Intas’ Imuldosa™ (approved January 2026, not yet launched).

First Wave of Generic Ozempic® (Semaglutide) Approvals Underway in South America with Sandoz/Adalvo’s Owozy®

On 29 July 2026, Sandoz announced that Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has approved Owozy® (semaglutide), a generic version of Novo Nordisk’s Ozempic®, for type 2 diabetes.  Sandoz is expecting to launch the product in the second half of 2026.

Owozy® was developed by Malta-headquartered Adalvo and will be commercialised in Brazil by Sandoz in a pre-filled, multi-dose disposable pen.  The Brazilian market for GLP-1 is estimated to be worth USD 1.8 billion, with more than 16.5 million Brazilians living with diabetes.

The Brazilian approval comes just weeks after Sun Pharma’s generic semaglutide injection was approved in South Africa (announced 15 July 2026), with launch following shortly thereafter.  A number of generic semaglutide products have also launched in India and Canada.  In March 2026, Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark launched generic semaglutide products on the Indian market, following the expiry of Novo Nordisk’s core Indian patent for semaglutide.  Generic semaglutide products were launched in Canada in May 2026 by Apotex and Dr Reddy’s.

Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.  Novo Nordisk has sued Apotex in the US in relation to generic Rybelsus®, Ozempic® and Wegovy®, alleging patent infringement, with the three cases being consolidated in June 2026.  Novo Nordisk also commenced Hatch Waxman litigation against Cipla in July 2026 in relation to generic semaglutide products.

EPO Board of Appeal Upholds Revocation of BMS’ Opdivo® (Nivolumab) Patent

On 29 July 2026, the EPO published the Board of Appeal’s decision of 6 May 2026 upholding the Opposition Division’s 13 March 2024 revocation of EP 3 288 980, for a composition comprising nivolumab for use in a method of treating PD-L1-positive melanoma.  The patent was opposed by 5 “strawperson” opponents.

The Boards of Appeal concluded that the claimed subject-matter of the patent, in particular the combination of nivolumab monotherapy and a flat-dose regimen (480 mg once every four weeks), extended beyond the content of the application as filed and did not meet the requirements of Article 123(2) of the EPC.

Multiple nivolumab biosimilars are under development including Sandoz’s JPB898Xbrane/Intas’ Xdivane™Amgen’s ABP 206Reliance Life Sciences’ RLS-NivolumabEnzene’s candidateBoan Biotech’s BA1104, and NeuClone’s candidate.

Pearce IP BioBlast® for the week ending 24 July 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 24 July 2026 are set out below:


Bevacizumab

On 24 July 2026, Outlook Therapeutics announced that the FDA has approved ONS-5010/Lytenava™ (bevacizumab-vikg) for the treatment of neovascular age-related… Read more here.

Denosumab

On 23 July 2026, Accord BioPharma announced its US launch of Osvyrti® and Jubereq® (denosumab), interchangeable biosimilars to Amgen’s Prolia® and Xgeva®… Read more here.

Denosumab, Ranibizumab, Pembrolizumab, Aflibercept, Adalimumab

On 22 July 2026, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) published the agenda for its November 2026 meeting, with a number of biosimilars… Read more here.

Nivolumab

21 July 2026 | RU | Biocad Secures First Biosimilar to BMS’ Opdivo® (Nivolumab) Approved in Russia
On 21 July 2026, GxP News reported that Biocad has received marketing authorisation from Russia’s Ministry of Health for Nivocad®, biosimilar to BMS’ Opdivo®… Read more here.

Pegfilgrastim, Ranibizumab

24 July 2026 | EU | July 2026 CHMP Positive Opinions Include CuraTeQ’s Biosimilar to Amgen’s Neulasta® (Pegfilgrastim) and Roche’s Susvimo® (Ranibizumab)
On 24 July 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its July 2026 meeting… Read more here.


Pembrolizumab

14 July 2026 | DK | SW | MSD Defeats Halozyme’s Preliminary Injunction Application Seeking to Bar Subcutaneous Keytruda® (Pembrolizumab) in Denmark & Sweden
On 14 July 2026 The District Court of The Hague published its judgment dismissing Halozyme’s application for a preliminary injunction (PI) to prevent MSD from… Read more here.

Secukinumab

24 July 2026 | EU | Celltrion Submits EU Application for Biosimilar to Novartis’ Cosentyx® (Secukinumab)
On 24 July 2026, Celltrion announced that it has submitted an application for marketing approval to the European Medicines Agency (EMA) for CT-P55, biosimilar to… Read more here.

Semgalutide

17 & 21 July 2026 | US | Novo Nordisk Sues Cipla for Patent Infringement and Eli Lilly for False Advertising in US Regarding Ozempic®/Wegovy® (Semaglutide)
Novo Nordisk has commenced Hatch-Waxman litigation in the US against both Cipla and Apotex in relation to their generic versions of Novo Nordisk’s semaglutide… Read more here.

Trastuzumab emtansine

22 July 2026 | IN | Intas’ Biosimilar to Roche’s Kadcyla® (Trastuzumab Emtansine) Approved in India
On 22 July 2026, the Economic Times reported that Intas Pharmaceuticals has received marketing approval from India’s Central Drug Standard Control Organisation… Read more here.

Ustekinumab

22 July 2026 | AU | Medtas Launches Pharmacy Support Program in Australia for Wezlana®, Biosimilar to Janssen’s Stelara® (Ustekinumab)
On 22 July 2026, Medtas announced that it has launched a new in-pharmacy program (myMedtas-Care), following the 1 July 2026 listing of Wezlana®, biosimilar to… Read more here.

Biopharma Deals

On 20 July 2026, Samsung Biologics announced that it has entered into an all-cash public tender to acquire 100% of PolyPeptide Group AG, a leading Swiss-based… Read more here.

Biopharma News

On 23 July 2026, Samsung Bioepis published the 14th edition of its US Biosimilar Market Report, which has been released every quarter since April 2023.  The report… 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 & Trade Mark Attorney (Trans Tasman)

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.

New Indication Alert: AstraZeneca/Daiichi’s Enhertu® (Trastuzumab Deruxtecan) + THP Approved in India for HER2-Positive Breast Cancer

On 28 July 2026, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan), followed by taxane, trastuzumab and pertuzumab (THP)), for the neoadjuvant treatment of HER2-positive stage 2 or 3 breast cancer.  This follows the conditional approval granted in China in March 2026 for Enhertu® followed by paclitaxel, trastuzumab and pertuzumab (THP) for the same indication.

Enhertu® was approved in India in May 2025 for the treatment of adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer, who have previously received at least one endocrine therapy in metastatic setting.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Daiichi Sankyo is solely responsible for manufacturing and supply.

Samsung Epis announced in January 2026 that Samsung Bioepis is adding a trastuzumab deruxtecan biosimilar to its pipeline, with the product in early stage development in preparation for pre-clinical trials.

Roche Sues Biocon on 28 US Pertuzumab Patents

On 26 July 2026, Roche and Genentech commenced BPCIA proceedings in the US District Court in New Jersey against Biocon in relation to Biocon’s Bmab 1500, biosimilar to Genentech’s Perjeta®.  The litigation arises from Biocon’s submission of an abbreviated Biologics License Application (aBLA), the date of filing of which is confidential.

Roche/Genentech allege Biocon infringes 28 US patents for inventions related to Perjeta® and various manufacturing methods for antibody production, covering pertuzumab as well as its use and manufacture.  Roche and Genentech are seeking “a preliminary and/or permanent injunction” to prevent Biocon from launching any product in the US that infringes the asserted patents, and damages.

The litigation follows Genetech’s February 2026 ITC complaint against Biocon’s importation of Bmab 1500 into the US.  In the ITC complaint, Genentech alleges that on 18 October 2025, Biocon imported more than 17,800 units of BMAB 1500 into the US from India before it received FDA approval.

Roche/Genentech filed BPCIA proceedings in the US District Court for the District of New Jersey in August 2025 against Shanghai Henlius and Organon in relation to their pertuzumab biosimilar, Poherdy® (FDA-approved in November 2025).  Those proceedings were settled in January 2026 on confidential terms.  In March 2026, Genentech commenced legal proceedings against Biocad before the Moscow Arbitration Court alleging patent infringement due to Biocad’s Pertuvia™ (approved in Russia in May 2025).  Court action by Roche against Zydus regarding its pertuzumab biosimilar, Sigrima®, has been running in India since the Indian approval of the product in June 2024.

Celltrion Submits EU Application for Biosimilar to Novartis’ Cosentyx® (Secukinumab)

On 24 July 2026, Celltrion announced that it has submitted an application for marketing approval to the European Medicines Agency (EMA) for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab), seeking all approved reference indications.

The announcement follows Celltrion’s applications for CT-P55 in Canada in May 2026 and Korea in June 2026.  Celltrion is also planning a regulatory filing for CT-P55 in the US.

Celltrion presented results from its Phase 1 trial for CT-P55 in September 2025.  In February 2026, Celltrion received approval from the EMA to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55.  Celltrion expects this will shorten the overall clinical timeline and reduce development expenses 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).  In June 2026, CSPC Pharmaceutical announced that China’s National Medical Products Administration (NMPA) had accepted a marketing authorisation application for its Secukinumab Injection.

July 2026 CHMP Positive Opinions Include CuraTeQ’s Biosimilar to Amgen’s Neulasta® (Pegfilgrastim) and Roche’s Susvimo® (Ranibizumab)

On 24 July 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its July 2026 meeting, including positive opinions for one biosimilar and two biopharmaceuticals.

Aurobindo Pharma subsidiary, CuraTeQ Biologics, received a CHMP recommendation for Cavoley™, biosimilar to Amgen’s Neulasta® (pegfilgrastim), as 6 mg solution for injection in a pre-filled syringe.  CuraTeQ has previously had a pegfilgrastim biosimilar approved in the EU under the name Dyrupeg® (March 2025).  Although it has been over 7 years since the approval of the first European pegfilgrastim biosimilar (Accord Healthcare’s Pelgraz®, September 2018), companies continue to pursue pegfilgrastim biosimilars in Europe, with Qilu Pharma obtaining a positive CHMP opinion for Nylaspeg™ (pegfilgrastim) last month.

The CHMP has also recommended marketing authorisation for Roche’s Susvimo® (ranibizumab) as a 100 mg/ml solution for injection.  Susvimo® is delivered via an ocular implant (Contivue™) for continuous release into the vitreous of the eye for the treatment of nAMD.  Susvimo® was approved in the US for nAMD in July 2024 and for DME in February 2025.  The US approvals followed an update and relaunch of the product, after Roche conducted a voluntary recall of the initial version (FDA approved in October 2021) as a result of test results showing some implants did not perform to Roche’s standards.

A positive CHMP opinion was also adopted for LIB Therapeutics’ Lyrokaul® (lerodalcibep), a recombinant fusion protein containing a PCSK9 inhibitor, which is indicated for treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia as an adjunct to diet.  The drug was launched in the US (under the name Lerochol®) in May 2026.

At its July 2026 meeting, the CHMP also recommended expanded indications for a number of medicines, including:

FDA Approves Outlook Therapeutics’ Lytenava™ (Ophthalmic Bevacizumab) Following 3 CRLs

On 24 July 2026, Outlook Therapeutics announced that the FDA has approved ONS-5010/Lytenava™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD/wet AMD).  Outlook expects Lytenava™ will be available to eligible patients in the US before the end of 2026.

Lytenava™ is the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of nAMD.  Outlook Therapeutics considers that Lytenava will have 12 years of Reference Product Exclusivity under the US BPCIA.

Since Outlook’s initial BLA submission for ONS-5010/Lytenava™ in 2022, the FDA issued three Complete Response Letters (CRL) to Outlook (in August 2023, August 2025 and December 2025).  After a Type A meeting in March 2026, Outlook requested a Formal Dispute Resolution (FDR) process.  In May 2026, the FDA granted the appeal, concluding that substantial evidence of effectiveness had been established for Lytenava™ for the treatment of wet AMD, despite the third CRL to the contrary.  The FDA accepted Outlook’s resubmitted Biologics License Application for Lytenava™ in June 2026 with a Prescription Drug User Fee Act target date of 29 July 2026.

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.

Samsung Bioepis Publishes Q3/2026 US Biosimilar Market Report – Ustekinumab Market Share at 42%

On 23 July 2026, Samsung Bioepis published the 14th edition of its US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

According to the Report, as of June 2026, the FDA had approved 96 biosimilars across 21 unique biosimilar molecules, 71 of which have been launched.  Since the Q2/2026 report, the biosimilars approved are Lupin’s Ranluspec® (ranibizumab) (referencing Genentech’s Lucentis®), Bio-Thera Solutions/Accord’s Immgolis™ and Immgolis Intri™ (golimumab) (referencing Janssen’s Simponi®/Simponi® Aria), Accord’s Ennumo™ (pegfilgrastim) (referencing Amgen’s Neulasta®) and Sunshine Lake Pharma’s Langlara™ (insulin glargine) (referencing Sanofi’s Lantus®).  The Q2/2026 biosimilar launches in the US were Biocon’s Bosaya® and Aukelso® (denosumab) (referencing Amgen’s Prolia® and Xgeva®).

Samsung Bioepis reports that immunology biosimilars within 5 years of launch (adalimumab, tocilizumab and ustekinumab) show strong growth in the US, with average biosimilar market penetration increasing by 25% year on year.  Notably, ustekinumab biosimilar penetration is increasing at a “significantly faster pace” compared with adalimumab biosimilars, although both are immunology products “mainly covered under the pharmacy benefit”.  As of Q1/2026, ustekinumab biosimilar market share had reached 42%, up 15% on the previous quarter.

FDA-approved ustekinumab biosimilars on the US market are: Amgen’s Wezlana® (FDA-approved October 2023; launched January 2025), Samsung Bioepis’ Pyzchiva® (approved July 2024, launched February 2025), Dong-A ST/Accord BioPharma’s Imuldosa® (approved October 2024; launched August 2025; added to ESI’s commercial formulary December 2025), Alvotech/Teva’s Selarsdi® (approved April 2024; launched February 2025; interchangeability status May 2025), Biocon’s Yesintek® (approved December 2024; launched February 2025), Formycon/Fresenius Kabi’s Otulfi® (approved September 2024; launched March 2025), Celltrion’s Steqeyma® (approved December 2024; launched March 2025) and Hikma’s Starjemza™ (approved May 2025; launched November 2025).

Accord BioPharma Launches Osvyrti® & Jubereq® (Denosumab), Biosimilars to Amgen’s Prolia® & Xgeva®, in US

On 23 July 2026, Accord BioPharma announced its US launch of Osvyrti® and Jubereq® (denosumab), interchangeable biosimilars to Amgen’s Prolia® and Xgeva®, respectively.  The denosumab biosimilars are the first products of Accord developed and manufactured “end to end” by its parent company, Intas Pharmaceuticals.

Osvyrti® and Jubereq® were approved by the FDA in November 2025.  Intas/Accord settled BPCIA litigation with Amgen in relation to the denosumab biosimilars in July 2025, with the settlement permitting their US launch from 1 October 2025 (subject to regulatory approval).  The US launch of the products comes over 7 months after their European launch in December 2025 (Jubereq® and Osvyrti® having been EU-approved in May 2025).

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 2024, launched June 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (approved February 2025, Ospomyv™ included on US formularies from 1 April 2026), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025; launched January 2026) and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

Medtas Launches Pharmacy Support Program in Australia for Wezlana®, Biosimilar to Janssen’s Stelara® (Ustekinumab)

On 22 July 2026, Medtas announced that it has launched a new in-pharmacy program (myMedtas-Care), following the 1 July 2026 listing of Wezlana®, biosimilar to Janssen’s Stelara® (ustekinumab), on the Australian Pharmaceutical Benefits Scheme (PBS).  The in-pharmacy program allows credentialled community pharmacists to administer subcutaneous Wezlana® injections for patients.

Wezlana® is manufactured by Amgen and is the first ustekinumab biosimilar in Australia to be PBS-listed across all product formats of the originator.  It is currently listed in 130 mg and 45 mg vial, and 45 mg and 90 mg pre-filled syringe, presentations.

The only other ustekinumab biosimilar currently PBS-listed in Australia is Celltrion’s Steqeyma® (1 August 2025).  Steqeyma® is not PBS listed in the 45 mg vial presentation.

Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting, but has not yet progressed to PBS listing, pending lodgement of required documentation.  Sandoz’s Ardelya® (ustekinumab) was recommended for PBS listing at the March 2026 PBAC meeting but is yet to receive marketing approval in Australia.

Intas’ Biosimilar to Roche’s Kadcyla® (Trastuzumab Emtansine) Approved in India

On 22 July 2026, the Economic Times reported that Intas Pharmaceuticals has received marketing approval from India’s Central Drug Standard Control Organisation (CDSCO) for its trastuzumab emtansine biosimilar, referencing Roche’s Kadcyla®.  No launch plans have been announced to date.

The biosimilar is approved for the same indications as the reference medicine and will be available in 100mg and 160mg single-dose vials for intravenous administration.

The approval was granted based on positive Phase III clinical trial results, which demonstrated the pharmacokinetics, efficacy, safety, and immunogenicity of the biosimilar compared to Roche’s Kadcyla®.  Marketing approval was recommended by the CDSCO, subject to Intas conducting a Phase IV (post-marketing) study in India and submitting the Phase IV clinical trial protocol within three months of the grant of marketing authorisation.

The first reported Kadcyla® biosimilar was Zydus’ Ujvira®, which was launched in India in May 2021.

November 2026 PBAC Agenda Includes Biosimilars to Amgen’s Prolia® & Xgeva® (Denosumab) & Genentech’s Lucentis® (Ranibizumab), Plus More

On 22 July 2026, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) published the agenda for its November 2026 meeting, with a number of biosimilars and biopharmaceuticals to be considered for reimbursement.

New Biosimilar Listings

PBAC will consider the following applications for reimbursement of biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) for the first time: Accord Healthcare’s Denolia® and Deskleta® in 60mg/1mL pre-filled syringe (PFS), and Dexeva® and Dostiva® in 120mg/1.7mL PFS (each TGA-approved in October 2025).

Amgen’s Prolia® and Xgeva® are now sponsored in Australia by Arrotex, following a 2024 deal between the companies.  Denosumab biosimilars currently listed on the Pharmaceutical Benefits Scheme (PBS) are Sandoz’s Wyost® and Jubbonti® (PBS-listed 1 August 2025), Amgen’s supplemental denosumab brands Corora® and Ganvado® (PBS-listed 1 September 2025, sponsored by Arrotex) and Celltrion’s Stoboclo® and Osenvelt® (PBS-listed 1 March 2026).

The following biosimilars to Genentech’s Lucentis® (ranibizumab) will also be considered at the November PBAC meeting:

  • Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved in February 2026); and
  • Generic Health’s Solentis® and Simulara® in 1.65mg/0.165mL PFS and 2.3mg/0.23mL PFS (not yet TGA-approved).

The only other approved ranibizumab biosimilar in Australia is Samsung Bioepis’ Byooviz® (approved August 2022), which is not currently PBS-listed.

Amended Biosimilar Listings

Amgen has submitted a request for a “broad listing” of Amgevita® (for the higher concentration forms recommended by PBAC at its March 2026 meeting: 20mg/0.2ml & 40mg/0.4ml PFS and 80mg/0.8ml pre-filled pen (PFP)) for the treatment of immune-mediated inflammatory disease.

Originator Biopharmaceuticals

MSD is requesting PBS listing of a new subcutaneous form of Keytruda® (pembrolizumab) (in two different strengths) under the same circumstances and for the same indications as the currently listed intravenous form.  The TGA approved both strengths of Keytruda SC™ (395mg/2.4mL and 790mg/4.8mL) on 23 July 2026.

Roche has resubmitted its request to list Susvimo® (ranibizumab), a solution for ocular implant (39.5mg/0.395mL), for the treatment of wet AMD.  This follows the PBAC’s decision against recommending PBS-listing of Susvimo® at its May 2026 meeting, on the basis that Roche was seeking TGA approval for an updated version of the port delivery system for the medicine.

Bayer has submitted a request to list high dose Eylea® (aflibercept, 8mg) in 114.3mg/mL intravitreal injection for the treatment of visual impairment due to macular oedema following branch or central retinal vein occlusion (RVO).  Eylea® 8mg has been PBS-listed for nAMD and diabetic macular oedema since 1 November 2024.

Dr Reddy’s Laboratories has submitted a request to list a new indication of Zytorvi® (toripalimab) in 240mg/6mL solution for IV infusion, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC).  Zytorvi® was first listed on the PBS on 1 December 2025 for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma.

Pearce IP BioBlast® for the week ending 17 July 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 17 July 2026 are set out below:


Cetuximab

On 14 July 2026, Merck KGaA announced that Erbitux® (cetuximab) was approved by the European Commission for adults with BRAF V600E mutant metastatic… Read more here.

Daratumumab

On 13 July 2026, Shanghai Henlius Biotech announced that the first patient in the US has been dosed in its international multicentre Phase 1 clinical trial of… Read more here.

Guselkumab

On 15 July 2026, Celltrion announced that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved its investigational new drug application to… Read more here.

Nivolumab

16 July 2026 | CN | Shanghai Henlius Doses First Patient in China in Ph 1 Trial for Biosimilar to BMS’ Opdivo® (Nivolumab)
On 16 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its international multicentre Phase 1 clinical trial of HLX18… Read more here.

Pembrolizumab

14 July 2026 | EU | Celltrion Terminates European Ph 3 Trial for Biosimilar to MSD’s Keytruda® (Pembrolizumab)
On 14 July 2026, ChosunBiz reported that Celltrion has voluntarily terminated the European Phase 3 trial of CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab)… Read more here.


Semaglutide

15 & 18 July 2026 | ZA | Sun Pharma’s Generic Semaglutide Approved & Novo Nordisk to Launch Low-Cost Ozempic® in South Africa
On 15 July 2026, Sun Pharma announced that the South African Health Products Regulatory Authority (SAHPRA) has approved its semaglutide injection, generic… Read more here.

Ustekinumab

16 July 2026 | AU | Organon & Samsung Bioepis Expand Biosimilar Development and Commercialisation Agreement in Australia
On 16 July 2026, Organon and Samsung Bioepis announced the expansion of their development and commercialisation agreement for Australia, to include a new… Read more here.
 
 
13 July 2026 | US | Samsung Bioepis Secures Preferred Formulary Status for Biosimilar to Janssen’s Stelara® (Ustekinumab) with 2 US PBMs
On 13 July 2026, Seoul Economic Daily reported that Samsung Bioepis has secured US formulary listings for Pyzchiva®/SB17, with two major pharmacy benefit… Read more here.

Biopharma Deals

On 14 July 2026, Formycon and OneSource Speciality Pharma announced that they have entered into a strategic manufacturing partnership for biosimilars… Read more here.
 
 
On 9 July 2026, Samsung Bioepis announced it signed a licence option agreement with Proteina, a Korean biotechnology company, to use the results of an R&D… Read more here.

Biopharma News

On 14 July 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety (MFDS) is implementing a revised notice on the Regulation… 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 & Trade Mark Attorney (Trans Tasman)

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.

Biocad Secures First Biosimilar to BMS’ Opdivo® (Nivolumab) Approved in Russia

On 21 July 2026, GxP News reported that Biocad has received marketing authorisation from Russia’s Ministry of Health for Nivocad®, biosimilar to BMS’ Opdivo® (nivolumab), for the treatment of various cancers.  This is the first biosimilar nivolumab to be approved in Russia.

Nivocad® is approved for the same indications as the reference product.  Nivolumab is included on Russia’s Vital and Essential Drugs list, which allows for increased accessibility for patients.

Zydus’ Tishtha™ was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024), following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.

Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, and NeuClone’s candidate.  Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Sandoz streamlining its biosimilar nivolumab clinical trials.

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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