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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 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 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.

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 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.

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.

Patent Pending, Injunction Ending… The Federal Court Steps into the Ring

 

Date of decision: 2 June 2026
Body: Federal Court of Australia
Adjudicator:
Justice Stellios

Introduction

Justice Stellios, sitting as duty judge in the Federal Court of Australia, has granted a mandatory interlocutory injunction requiring RedTail Technology Pty Ltd (RedTail) and its founder and sole director, secretary and shareholder (Richard Pahlavani), to withdraw all patent applications that claim priority from Australian Patent Application number 2024904131 titled “LASER DIRECTOR, AN ELECTROMAGNETIC SPECTRUM DENIAL DEVICE, A POINTING SYSTEM AND A WEAPON SYSTEM”, including any applications filed under the Patent Cooperation Treaty.

The Applicants, EOS Space Systems Pty Limited and EOS Defence Systems Pty Limited (EOS), claim that making the patent applications amounted to misuse of information and other unlawful conduct by RedTail and Mr Pahlavani based on his previous employment by the Applicants.  The mandatory interlocutory injunction application was brought on an urgent basis, with the proceedings commenced on Friday 29 May 2026, the hearing of the application occurring on Monday 1 June 2026 and Justice Stellios delivering his decision on Tuesday 2 June 2026. The proceedings continue, with the case now in the hands of Justice Moore, with a case management hearing before Justice Moore scheduled for 6 August 2026.

Background

EOS is in the business of designing and manufacturing advanced technology systems including remote weapon systems, high energy laser weapons, AI-enabled command-and-control for layered counter-drone capability, and ground-based space control capabilities for precision tracking, intelligence and deterrence. EOS’ clients include defence and military forces around the world.

EOS had employed Mr Pahlavani as a laser engineer between January 2021 and March 2024. Mr Pahlavani’s employment contract with EOS contained confidential information and intellectual property clauses. While at EOS, Mr Pahlavani worked on a project relating to a laser system or anti-drone system (Laser Rifle).

Mr Pahlavani resigned from EOS in March 2024. He then incorporated RedTail in August 2024. In December 2024, RedTail filed a provisional patent application: Australian Patent Application number 2024904131 entitled “LASER DIRECTOR, AN ELECTROMAGNETIC SPECTRUM DENIAL DEVICE, A POINTING SYSTEM AND A WEAPON SYSTEM” (the 131 Application), with an application subsequently being filed under the Patent Cooperation Treaty (the PCT Application).

EOS alleged that Mr Pahlavani had used and/or disclosed, without permission, confidential information obtained from his employment with EOS in preparing these patent applications.

Key Issues

EOS filed these proceedings seeking orders permanently restraining Mr Pahlavani and RedTail from using/disclosing confidential information obtained from Mr Pahlavani’s employment with EOS (the Confidential Information), pecuniary relief, and delivery and destruction of the information.

EOS sought this relief on the basis that Mr Pahlavani had allegedly:

(1)    contravened s 183 of the Corporations Act 2001 (Cth);

(2)    breached an equitable obligation of confidentiality owed to EOS;

(3)    breached the terms of his employment contract with EOS; and

(4)    breached his fiduciary duty to EOS

EOS also alleged that RedTail had been knowingly involved in Mr Pahlavani’s contravention of s 183 of the Corporations Act, had breached an equitable obligation of confidentiality owed to EOS, had induced Mr Pahlavani’s breach of his employment contract, and had been knowingly involved in Mr Pahlavani’s breach of fiduciary duty to EOS.

Critically, EOS also sought an urgent mandatory interlocutory injunction requiring RedTail (and Mr Pahlavani) to withdraw all patent applications that claim priority from the 131 Application, including any applications filed under the Patent Cooperation Treaty. It is this mandatory interlocutory injunction application which was the subject of Justice Stellios’ decision.

Justice Stellios decided the mandatory interlocutory injunction application on the basis of the alleged contravention of s 183(1) of the Corporations Act. Section 183(1) provides that a person who obtains information because they are, or have been, a director or other officer or employee of a corporation must not improperly use the information to (a) gain an advantage for themselves or someone else or (b) cause detriment to the corporation.

Justice Stellios applied the undisputed principles applicable to interlocutory injunction applications in determining whether to grant the injunction, namely:

  • Whether there was a serious question to be tried;
  • Whether the balance of convenience favoured the making of the order; and
  • Whether damages would not be an adequate remedy.

In addition to these undisputed principles, Mr Pahlavani and RedTail submitted that the mandatory character of the interlocutory injunction (which required RedTail and Mr Pahlavani to perform a specific positive action i.e. to withdraw the patent applications) should be a factor that weighs heavily against the order being made. While Justice Stellios considered that the fact that the order sought required Mr Pahlavani and RedTail to take certain action was a factor to consider on the interlocutory application, his Honour also considered that the character of the order was akin to an order that would have restrained them from filing the patent applications if the order had been sought beforehand. Accordingly, the order sought could in substance be characterised as an order to refrain from prosecuting the patent applications.

Serious Question to be Tried

EOS succeeded in persuading Justice Stellios that there was a serious question to be tried in respect of the alleged contravention of s 183(1) of the Corporations Act. His Honour considered that the uncontested expert evidence filed by EOS established that concepts that formed part of the EOS project on the Laser Rifle (to which Mr Pahlavani contributed and in relation to which he had access) were concepts forming part of the PCT Application. This led to the conclusion that there was a serious question to be tried as to whether Mr Pahlavani improperly used information obtained because he was an EOS employee to gain an advantage for himself and for RedTail.

In reaching this conclusion, Justice Stellios rejected the following arguments from Mr Pahlavani and RedTail:

  • That EOS had not specifically identified the information alleged to be confidential. His Honour disagreed, finding that the confidential information had been specifically identified, with his Honour’s view being strengthened by the fact that Mr Pahlavani had been able to “engage” with the alleged confidential information allegations.
  • That the alleged confidential information was not in fact confidential. His Honour considered that the position was not presently clear on the evidence before him and, so, it did not displace the existence of a serious question to be tried. Further, his Honour noted that s 183(1) of the Corporations Act required consideration of whether Mr Pahlavani and RedTail had improperly used information (not confidential information).
  • That EOS’ actions had given rise to an estoppel on the basis that Mr Pahlavani had allegedly disclosed that he had a pre-existing project to EOS and EOS had agreed that he could continue to own and develop the technology the subject of that pre-existing project. His Honour considered that the possibility of an estoppel argument was insufficiently clear to undermine the fact that there was a serious question to be tried.

Balance of Convenience

EOS then went on to successfully persuade his Honour that the balance of convenience favoured the grant of the mandatory interlocutory injunction.

EOS argued that:

  • If allowed to proceed, the PCT Application and the 131 Application would become public on or about 18 June 2026, so destroying the confidentiality of the information. This would impact EOS’ ability to commercialise its product (particularly given the nature of their customer base, being defence and government organisations which mandate strict confidentiality protocols), leading to lost future sales and significant waste of invested resources. Competitors would also potentially be able to reverse-engineer or replicate the technology.
  • Even if EOS was entitled to be assigned any patent arising from the PCT Application, that would not address the harm identified above. Justice Stellios considered that this factor and the previous factor weighed heavily in EOS’ favour.
  • EOS accepted that they might need to give an undertaking as to damages which would protect RedTail’s and Mr Pahlavani’s position.  In contrast, RedTail and Mr Pahlavani did not have the means to meet an adverse pecuniary relief order. This meant that, even if damages were an adequate remedy, there would likely be no compensation flowing to EOS. Justice Stellios accepted this submission.

In answer to EOS’s position, RedTail and Mr Pahlavani argued that:

  • They would suffer material prejudice, in particular that the injunction sought would put an end to the current patent applications. This would result in a lost opportunity to seek patent protection in multiple jurisdictions on the basis of the current priority date, and consequent financial loss for RedTail and Mr Pahlavani given the investment made in the patent applications. RedTail and Mr Pahlavani would also be unable to obtain outside investment in RedTail’s business because investors would be unwilling to invest in a product without patent protection. Further, EOS’ proffered undertaking would be insufficient to adequately address that prejudice, and damages would not be an adequate remedy. While his Honour accepted that RedTail and Mr Pahlavani would suffer the detriment outlined above and that there might be some challenges for any assessment of damages, Justice Stellios was not persuaded that the lost opportunity from the forced withdrawal of the patent applications was not compensable in the ordinary way. His Honour noted that EOS had offered the usual undertaking, and that it was uncontested that they had the financial means to satisfy an award for damages.
  • EOS had delayed bringing its application for a mandatory interlocutory injunction. While his Honour accepted that there had been some delay, Justice Stellios did not consider this delay to be disentitling.
  • EOS had approached the Court with unclean hands, including because of the matters that formed the basis of the estoppel claim. His Honour did not give weight to this argument.
  • There was no serious question to be tried. For the reasons set out above, his Honour did not give weight to this argument.
  • There was an alternative mechanism suggested to EOS, of seeking the redaction of passages from the PCT Application. RedTail’s and Mr Pahlavani’s counsel, however, conceded during the hearing that there would be no guarantee that such an option would be effective.

Outcome and Implications

Accordingly, Justice Stellios granted the mandatory interlocutory injunction, subject to EOS providing the usual undertaking as to damages. The 131 Application has now been withdrawn, with its status showing as “lapsed” on the Australian patents register.

Justice Stellios’ decision will be welcome news for employers for whom enforcement of confidentiality obligations owed by former employees is critical. His Honour’s decision continues the recent run of interlocutory injunction cases heard by the Federal Court of Australia in the context of patent disputes, albeit the fundamental dispute here related to an alleged misuse of confidential information. Justice Stellios’ decision illustrates the swiftness with which the Federal Court can hear and determine interlocutory injunction applications. Justice Stellios’ decision also illustrates the Federal Court’s willingness to grant an interlocutory injunction where the facts justify the grant of the injunction, even when, as in this case, the enjoined party loses the opportunity to pursue a valuable property (patent) right as a result.


 

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.

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

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

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

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

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

Samsung Biologics to Acquire PolyPeptide Group in CHF 1.46B Deal

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 global contract development and manufacturing organisation (CDMO), specialised in peptide-based active pharmaceutical ingredients.

Under the terms of the tender offer, PolyPeptide Group shareholders will receive CHF 44.31 in cash per share.  The transaction is expected to close at the end of 2026, subject to regulatory approvals and closing conditions.

This acquisition will allow Samsung Biologics to leverage PolyPeptide Group’s peptide-based capabilities and expand its current CDMO offerings beyond antibodies and ADCs, addressing growing demand for peptide-based therapeutics, particularly in obesity and diabetes, including GLP-1 therapies.

Following the November 2025 spin-off of biosimilar operations into a new holding entity, Samsung Epis Holdings, Samsung Biologics has focused on its contract development and manufacturing business.

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 products.

Most recently, on 17 July 2026, Novo Nordisk filed a Complaint against Cipla in the US District Court for the District of New Jersey alleging that Cipla’s generic version of Novo Nordisk’s Ozempic® (semaglutide) infringes four US patents which cover Ozempic® and/or its use: US 8,129,343, US 10,335,462, US 12,295,988 and US 12,569,543.  The complaint arises from Cipla’s submission of an Abbreviated New Drug Application (ANDA) seeking approval to market generic Ozempic® in dosage strengths of 2 mg/3ml, 4 mg/3ml and 8 mg/3ml.

Novo Nordisk had previously commenced litigation in the same Court against Apotex on 10 October 2024 in relation to generic Rybelsus® (semaglutide), on 20 February 2026 in relation to generic Ozempic® tablets® and on 29 April 2026 in relation to generic Wegovy® (semaglutide).  Orders were made by the Court on 12 June 2026 consolidating the three actions.  Apotex received the first US FDA Tentative Approval for its generic Ozempic® ANDA in April 2026, signifying that Apotex’s product meets all statutory and regulatory requirements for approval but cannot be marketed in the US because of patents or exclusivities related to the reference drug.

Novo Nordisk also has patent litigation pending in the US District Court for the District of Delaware against each of Sun Pharmaceutical and Mylan in relation to generic Wegovy®, which was commenced in September 2024.

Meanwhile, on 21 July 2026, Novo Nordisk filed a false advertising lawsuit against Eli Lilly in the US District Court for the District of New Jersey, alleging that Eli Lilly’s nationwide, direct-to-consumer advertising campaigns for GLP-1 medicines are designed to mislead the public about the comparative effects of those medicines for weight loss and type 2 diabetes.

Novo Nordisk claims that Eli Lilly’s ads falsely tell consumers that Zepbound® (tirzepatide) helps patients lose significantly more weight than Novo Nordisk’s Wegovy® and that Eli Lilly’s Mounjaro® (tirzepatide) reduces a key measure of blood sugar control for type 2 diabetes patients significantly more than Novo Nordisk’s Ozempic®.  According to Novo Nordisk, in both cases, the ads are false and misleading because Eli Lilly seeks to support its representations with outdated clinical trials that compare the highest dose of Zepbound®/Mounjaro® to lower doses of Novo Nordisk’s medicines, when there are newer, more effective does of Novo Nordisk’s products available.

Novo Nordisk is seeking preliminary and permanent injunctions preventing Eli Lilly from continuing to disseminate the comparative advertising, as well as damages and corrective advertising.

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 biosimilar.  While the biosimilar has not been named by Organon or Samsung Bioepis, Pharma in Focus has suggested that it may be Epyztek®, biosimilar to J&J’s Stelara® (ustekinumab).

Under the terms of the expanded agreement, Organon will obtain the exclusive Australian commercialisation rights to the biosimilar, while Samsung Bioepis will maintain full development, manufacturing and regulatory responsibilities.

Samsung Bioepis’ Epyztek® (ustekinumab) was approved in Australia in October 2024 and was recommended for PBS-listing at PBAC’s March 2025 meeting.  The drug has not yet been PBS-listed pending lodgement of required documentation.

In October 2025, Samsung Bioepis successfully opposed Janssen’s Australian patent application (AU2019346134) relating to a method of treating ulcerative colitis (UC) with Stelara® (ustekinumab).

This followed a decision of the Federal Court of Australia in June 2025, ordering that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  In an earlier victory for Samsung Bioepis, Janssen surrendered two innovation patents (AU 2023100041 and 2023100042), which related to methods of treating UC with ustekinumab.

Organon is currently sponsoring three of Samsung Bioepis’ biosimilars in Australia under the existing agreement: Brenzys® (etanercept), which was TGA-approved July 2016 and PBS-listed July April 2017; Renflexis® (infliximab), TGA-approved November 2016 and PBS-listed August 2017; and Hadlima® (adalimumab), TGA-approved in January 2018, launched March 2021 and PBS-listed in April 2021.

In June 2026, the companies announced the expansion of their Canadian collaboration, first established in 2013, from five to six biosimilars to include Pyzchiva®, biosimilar to J&J’s Stelara (ustekinumab).

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, biosimilar to BMS’ Opdivo® (nivolumab).

Henlius received approval from China’s National Medical Products Administration for the investigational new drug (IND) application for HLX18 in March 2026.  This followed FDA approval of the HLX18 IND application in December 2025.

The Phase 1 study, initiated in June 2026, is designed to evaluate the similarity in pharmacokinetic profile, efficacy, safety and immunogenicity of HLX18 and BMS’ Opdivo® in patients with resected oesophageal or gastroesophageal junction cancer, melanoma or urothelial carcinoma.  Primary completion of the study is expected in August 2027.

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.  In June 2026, Orion Pharma announced it entered into an agreement with Shilpa Biologicals for the European commercialisation of Shilpa’s intravenous nivolumab biosimilar, which is currently under development.

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.

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 equivalent of Novo Nordisk’s Ozempic® (semaglutide) for the treatment of adults with type 2 diabetes mellitus.  The launch is expected to occur in the coming days.

The semaglutide injection was approved as a pre-filled, multi-dose injectable pen in two strengths (2 mg/1.5 mL and 4 mg/3 mL) for once-weekly treatment of adult patients as an adjunct to diet and exercise.  This is the second market to date, following India, where Sun Pharma’s generic semaglutide has received approval.

On 18 July 2026, Business Insider Africa announced that Novo Nordisk is partnering with Swiss pharmaceutical company, Acino, to launch Extensior™, a lower-cost version of Ozempic® (semaglutide) on 27 July 2026 in South Africa.  Extensior™ will be available in 0.25mg, 0.5mg and 1mg doses in the same injection device as Ozempic®.  This followed Novo Nordisk securing an interim order from the Gauteng High Court preventing iDexis from manufacturing and selling compounded semaglutide medicines in South Africa in June 2026.  iDexis has appealed the court order and decisions made by SAHPRA and the South African Pharmacy Council.

A number of generic semaglutide products have already 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 recently launched alternative semaglutide formulations globally.  Novo Nordisk’s Wegovy® pill was the first oral GLP-1 treatment recommended for approval by CHMP for weight management in the EU.  Marketing authorisation for the Wegovy® pill and Wegovy® 7.2mg injection in a single-dose pen was granted by the European Commission on 15 July 2026.  This followed 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.

Celltrion Secures Korean Approval for Phase 1 Trial for Biosimilar to Janssen’s Tremfya® (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 commence a Phase 1 clinical trial of CT-P68, biosimilar to Janssen’s Tremfya® (guselkumab).

The Phase 1 trial will assess the safety and pharmacokinetic equivalence of CT-P68 and Tremfya® in 258 healthy adults.

No guselkumab biosimilars have yet been approved in any major market.  Guselkumab biosimilars are being developed by Polpharma Biologics, whose PB019 is licensed to MS Pharma in the MENA region, and Samsung Bioepis.  Alvotech also has a proposed guselkumab biosimilar in development, partnered with Advanz Pharma for commercialisation in the EU, UK and Switzerland.

Dead on Arrival – The Full Court Jumpstarts a Best Method Nightmare for Divisional Patentees

 

Date of decision: 10 April 2026
Body: Full Court of the Federal Court of Australia
Adjudicator:
Beach, Downes and Jackman JJ

Introduction

On 10 April 2026, the Full Court of the Federal Court of Australia delivered its decision in NOCO’s appeal from the primary judge’s decision in The NOCO Company v Brown and Watson International Pty Ltd [2025] FCA 887.  Our article on the primary judge’s decision is available here.

The Full Court dismissed NOCO’s appeal, rejecting NOCO’s challenges on obviousness and the correct priority date for assessing novelty.  Notably, however, the Full Court overturned the primary judge’s decision that the relevant date for assessing NOCO’s knowledge of the best method of performing the claimed inventions was the filing date of the priority document and not the later filing dates of each of the divisional applications containing the complete specifications for the patents in suit.  As a result, the Full Court assessed the best method ground at these later dates, finding that the specification for each of the patents did not disclose the best method known to NOCO of performing the invention.

Background

The case concerned three Australian patents held by NOCO, relating to portable vehicle battery jump starter apparatus with safety protection:

All three patents were from the same family, each claiming priority from PCT/US2014/045434 (PCT 434) filed on 3 July 2014 (the Asserted Priority Date).

The patents addressed safety problems with traditional jump starter devices, where jumper cables could accidentally contact each other or be connected with reverse polarity, causing sparking and potential injury.  The patented solution involved a control system that detected both battery presence and correct polarity before allowing a power switch to connect the internal battery to the external vehicle battery.

Although many claims were in issue, considerable attention was given to Claim 1 of the 223 Patent, which claims as follows (following the Court’s added integer sub-numbering):

1.1A jump starter apparatus for boosting or charging a depleted or discharged battery having a positive battery terminal and a negative battery terminal, the apparatus comprising:
1.2a power supply;
1.3a positive battery connector for connecting the jump starter apparatus to the positive battery terminal of the depleted or discharged battery;
1.4a negative battery connector for connecting the jump starter apparatus to the negative battery terminal of the depleted or discharged battery;
1.5a power switch connected in circuit with the power supply and the positive and negative battery connectors, the power switch configured to turn power on or off from the power supply to the positive and negative battery connectors;
1.6a control system or circuit connected to and controlling the power switch, the control system or circuit configured to detect presence of the depleted or discharged battery when connected between the positive and negative battery connectors and to detect polarity of the depleted or discharged battery when connected between the positive and negative battery connectors;
1.7wherein the control system or circuit switches on the power switch to connect the power supply to the depleted or discharged battery only when (1.7.1) the depleted or discharged battery is present and properly connected between the positive and negative battery connectors and (1.7.2) the depleted or discharged battery is properly connected with a correct polarity between the positive and negative battery terminals.

NOCO brought proceedings against B&W, alleging infringement of the patents by B&W’s ‘Projecta’ brand jump starters.  B&W cross-claimed, seeking to invalidate all asserted claims on grounds of lack of novelty, lack of inventive step, failure to disclose the best method, lack of support, insufficiency and lack of utility.

The lack of novelty ground depended largely on whether the three patents were entitled to the Asserted Priority Date of 3 July 2014.  The primary judge found that many of the asserted claims were not entitled to the Asserted Priority Date, and, given NOCO’s concession that claims not entitled to the Asserted Priority Date would be invalid for lack of novelty, these claims failed on that basis.  The primary judge found that all of the asserted claims were invalid for lack of inventive step, but concluded that the best method ground was not made out.  It was not necessary for the primary judge to consider the remaining grounds of invalidity.

Key Issues on Appeal

Lack of Inventive Step

The Full Court rejected all of NOCO’s grounds of appeal challenging the primary judge’s decision that all of the Asserted Claims were invalid for lack of inventive step.  In rejecting NOCO’s challenge to the primary judge’s findings, the Court stated (amongst other things) that:

  • The expert evidence established that the primary judge’s observation that inclusion of the arrangement in integers 1.6 and 1.7 in a jump starter device would have been a matter of routine involved an acceptance that there was a known problem, with a known solution, and the skilled person would choose and apply that solution without any difficulty in a jump starter having all the features of Claim 1 of the 223 Patent.
  • The primary judge did not fail to assess obviousness using the skilled team as a whole.  The primary judge combined the common general knowledge of each of the product designer and the electrical engineer comprising the notional team when concluding that the invention was obvious.
  • The primary judge was clearly alive to the issue of hindsight, and was satisfied that the expert evidence was not tainted or otherwise affected by any hindsight.
  • An invention may be obvious even if there are numerous other obvious routes as well.  It is therefore not a requirement to find that a skilled person would be motivated to follow a single path and no others.
  • When considering whether an invention is obvious in light of the common general knowledge plus a prior art document (under section 7(3) of the Patents Act), it is sufficient if the prior art document adds to the common general knowledge something that renders the claimed invention obvious in any relevant way.  Further, the question is not whether the prior art document would have led directly, and as a matter of routine, to the claimed invention, as that is not the question to which section 7(3) of the Act is directed.  Section 7(3) directs attention to the combination of information in the common general knowledge and the s 7(3) document.  And, the fact that a witness has reservations in respect of certain aspects of a document does not, without more, lead inevitably to the consequence that the skilled person would entirely disregard the document.

Priority Date

The Full Court also rejected all of NOCO’s grounds of appeal challenging the primary judge’s decision that none of the asserted claims were entitled to the Asserted Priority Date.  As a result, these claims lacked novelty as NOCO had conceded that claims not entitled to the Asserted Priority Date would be invalid for lack of novelty.

The Full Court agreed with the primary judge that the following two essential features in the priority document (PCT 434) were missing from the asserted claims:

  • The use of a FET switch which was consistently identified as essential (not merely illustrative) throughout PCT 434.  PCT 434 also did not disclose the possibility that other types of power switches, such as electromagnetic switches, might be used.  In contrast, the asserted claims encompassed the use of any type of power switch.
  • The use of two sensors to detect presence and polarity respectively which was consistently identified as essential in PCT 434.  In contrast, the asserted claims included claims which did not require the use of two sensors.

Accordingly, the invention claimed in each of the asserted claims was not disclosed in PCT 434, and so was not entitled to claim priority from PCT 434.

Best Method

At first instance, the primary judge had found that the relevant date for assessing NOCO’s knowledge of the best method of performing the claimed inventions was the filing date of PCT 434 (i.e. 3 July 2014), and not the later filing dates of each of the divisional applications containing the complete specifications for the Patents (being dates in 2020 to 2022).  If the relevant date was the date of filing PCT 434, this ground of invalidity failed.  However, if the relevant date was the filing date of each of the divisional applications containing the complete specifications for the Patents, then there was a factual issue as to whether NOCO was aware of a better method of performing the invention in 2020 to 2022 than that which was disclosed in each of the patents.

The Full Court overturned the primary judge’s decision on this point, finding that the language of the relevant statutory provisions and the previous judicial decisions supported the conclusion that the relevant date for ascertaining the patentee’s knowledge of the best method is the date of filing the complete specification for the patent in suit, not the earlier date of a PCT specification.

The Full Court also considered that to use such a time of filing did not create any unjustifiable asymmetrical burden on NOCO for the following reasons:

  • NOCO had, through the divisional applications, claimed an enlarged monopoly in comparison to that claimed in PCT 434.
  • The relevant claims in PCT 434 were limited to a jump starter with a FET switch and two sensors.  However, NOCO had discovered that such a switch was unreliable and removed that limitation from the relevant claims in the specifications in the divisional applications without disclosing that a different switch ought to be used.
  • Accordingly, it was appropriate that NOCO be required to make a disclosure corresponding to the enlarged monopoly claimed in the divisional applications.  Not to require such disclosure at the later time would be contrary to the policy underpinning the best method requirement and would allow NOCO to withhold knowledge of the best method known at that later time.

As a result, the Full Court held that the specification for each of the patents did not disclose the best method known to NOCO of performing the invention.

Outcome and Implications

Accordingly, the Full Court dismissed NOCO’s appeal and ordered that NOCO pay B&W’s costs of the appeal.  The Full Court’s decision provides valuable guidance on the test and relevant evidence for lack of inventive step, as well as the correct approach to determining whether a patent is entitled to a priority date earlier than its filing date.  Most importantly, the Full Court has confirmed that the relevant date for assessing a patentee’s knowledge of the best method of performing the claimed inventions is not the filing date of the priority document but is instead the later filing dates of each of the divisional applications containing the complete specifications for the patents in suit.  Patent attorneys will need to be cautious when recommending a divisional filing strategy to ensure that applicant clients are aware that they may have an obligation to update their disclosures of best method (if a better method has been developed in the intervening time period).


 

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.

 

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

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

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.

Pearce IP BioBlast® for the week ending 10 July 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 10 July 2026 are set out below:


Aflibercept

On 8 July 2026, Teva and Samsung Bioepis announced that they have entered an agreement for the commercialisation in Canada of Opuviz®/SB15 (aflibercept)… Read more here.

Bevacizumab

On 7 July 2026, Celltrion announced that it has successfully secured formulary listings for Vegzelma™, biosimilar to Roche/Genentech’s Avastin® (bevacizumab)… Read more here.

Cetuximab

On 8 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its multicentre Phase 1 clinical trial of HLX05-N, biosimilar to… Read more here.

Ocrelizumab

9 July 2026 | Teva Inks Licensing Deal with Polpharma Biologics for Biosimilar to Roche’s Ocrevus® (Ocrelizumab)
On 9 July 2026, Teva and Polpharma Biologics announced that they entered into an exclusive licensing agreement for the commercialisation of intravenous and… Read more here.

Pegfilgrastim

9 July 2026 | US | Accord BioPharma’s Biosimilar to Amgen’s Neulasta® (Pegfilgrastim) Approved in US
On 9 July 2026, PR Newswire reported that the FDA has approved Accord BioPharma’s Ennumo™, biosimilar to Amgen’s Neulasta® (pegfilgrastim), for all approved… Read more here.


Pembrolizumab

6 July 2026 | US | Celltrion Streamlines Ph 3 Global Trial for Biosimilar to MSD’s Keytruda® (Pembrolizumab)
On 6 July 2026, Seoul Economic Daily reported that Celltrion has filed with the FDA an amendment to its global Phase 3 clinical trial plan for CT-P51, biosimilar to MSD’s… Read more here.

Pembrolizumab, Isatuximab

10 July 2026 | US | FDA Approves Expanded Indication for MSD’s Keytruda®/Keytruda Qlex™ (Pembrolizumab) & SC Form of Sanofi’s Sarclisa® (Isatuximab)
On 10 July 2026, the FDA announced that it approved each of MSD’s Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase… Read more here.

Biopharma Deals

On 6 July 2026, Novartis and Myricx Bio announced that they have entered into an agreement for the acquisition of Myricx Bio by Novartis.  Myricx Bio is a UK-based… Read more here.
 
On 2 July 2026, Singaporean-headquartered Prestige Biopharma announced that it had signed a memorandum of understanding (MOU) with US-based Charles River… 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.

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 marketing Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) in Denmark and Sweden pending the outcome of substantive proceedings.

In the substantive proceedings, MSD is seeking a declaration of non-infringement and the revocation of the Dutch part of Halozyme’s European patent EP 2792622 (EP622), which expires on 27 December 2032.  EP622 relates to recombinant human modified PH20 hyaluronidase (rHUPH20) polypeptides.  Halozyme has cross-claimed for infringement of EP622, seeking cross-border injunctions covering all countries where the patent is in force, except Germany (where a PI is already in place).  The oral hearing in the substantive proceeding is scheduled for 31 July 2026.

The preliminary injunction application arose from a statement that MSD made in its reply to Halozyme’s cross-claim.  In that statement, MSD claimed that Halozyme’s suggestion that MSD intended to bring Keytruda SC™ to market “as quickly as possible” in the relevant EU countries was “unfounded and incorrect”.  Halozyme argued that this was a “binding undertaking” or at least created a legitimate expectation that MSD would not launch Keytruda SC™ in those countries before the conclusion of the main proceedings.  Halozyme argued this undertaking or expectation was breached by MSD’s subsequent conduct in listing Keytruda SC™ in the Swedish and Danish national pricing databases.

In deciding the PI application in favour of MSD, the Court found that MSD’s statement in its pleadings did not create an enforceable undertaking and Halozyme could not reasonably have interpreted the statement as a declaration of MSD’s intent without further verification.

MSD and Halozyme are also in dispute elsewhere over patents to Halozyme’s MDASE™ subcutaneous delivery technology.  In December 2025, the Munich Regional Court granted a PI to Halozyme, preventing MSD from distributing and offering for sale in Germany Keytruda SC™, based on a finding of the Court that there was imminent infringement of EP622.  In April 2024, Halozyme sued MSD in the US, alleging that MSD’s subcutaneous Keytruda® (Keytruda Qlex®) infringes 15 patents.  MSD has successfully invalidated claims of 4 of Halozyme’s US patents before the Patent Trial and Appeal Board (PTAB) and has a further 13 petitions pending before PTAB.

While there are no reports of biosimilar subcutaneous pembrolizumab development to date, there are multiple pembrolizumab biosimilars approved or in development.  Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).  Pembrolizumab biosimilars are also in clinical trials including by Formycon, Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.

Korea Eases Ph 3 Data Requirements for Biosimilar Approval

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 on Approval and Review of Biological Products.  The revisions permit Phase 3 clinical trial data to be waived for biosimilar approval applications if equivalence with the reference drug is sufficiently demonstrated through quality, non-clinical, and pharmacokinetic studies.

The change is aimed at accelerating biosimilar development and aligning Korean regulations with global standards.  The European, US and Canadian regulatory agencies have adopted similarly reduced requirements for Phase 3 clinical trial data, as follows:

Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Celltrion streamlining its US Phase 3 trial for biosimilar pembrolizumab and EU Phase 3 biosimilar secukinumab trial, Sandoz streamlining its nivolumab and ocrelizumab biosimilar trials and minimising its Phase 3 biosimilar pembrolizumab trial, and Formycon voluntarily terminating its Phase 3 clinical trial for biosimilar pembrolizumab.

Formycon Signs Strategic Biosimilar Manufacturing Partnership with OneSource

On 14 July 2026, Formycon and OneSource Speciality Pharma announced that they have entered into a strategic manufacturing partnership for biosimilars.  OneSource is an Indian-based specialty pharma Contract Development & Manufacturing Organisation (CDMO) that provides end-to-end services for complex pharmaceutical products.

Under the partnership, OneSource will provide integrated drug substance and drug product manufacturing capabilities from its biologics facility in Bangalore, to support the development of Formycon’s biosimilar programs for global markets.

Formycon’s CEO, Dr Stefan Glombitza, stated that “by adding OneSource to our network of strategic manufacturing partners, we are further strengthening our supply capabilities”.  Neeraj Sharma, OneSource’s Managing Director & CEO, added that this partnership “…reinforces our belief that India is uniquely positioned to serve as a global hub for the development and manufacturing of world-class biologics”.

In June 2025, Sweden-based Xbrane Biopharma and OneSource entered into a partnership for the commercial manufacture of Xbrane’s biosimilar portfolio.

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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