Other Updates

On 5 March 2026, Outlook Therapeutics provided an update on ONS-5010/Lytenava™, ophthalmic biosimilar to Roche/Genentech’s Avastin® (bevacizumab-vikg), following a Type A meeting with the U.S. Food and Drug Administration (FDA).

The Type A meeting was held to clarify an issue regarding substantial evidence of effectiveness identified in the third Complete Response Letter (CRL) issued in December 2025 for the ONS-5010/Lytenava™ Biologics License Application (BLA).  The meeting was also used to discuss potential regulatory approval steps.  Outlook Therapeutics stated it will continue to engage with the FDA to further clarify the FDA’s view on confirmatory evidence and the regulatory path forward.

The March 2026 Type A meeting is the second Type A meeting Outlook Therapeutics has held with the FDA for its ophthalmic bevacizumab biosimilar.  The first Type A meeting occurred in September 2025 to address the second CRL issued in August 2025.  The CRL recommended that Outlook Therapeutics submit additional confirmatory efficacy data to support its application.

Outlook Therapeutics had already resubmitted its BLA to the FDA in February 2025, following receipt of a first CRL from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials.  A second CRL (August 2025) recommended Outlook submit additional efficacy data to support its application for ONS-5010. Outlook Therapeutics resubmitted its BLA to the FDA in November 2025, in order to address the issues in the August 2025 CRL.

Lytenava™ received marketing authorisation in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025.  The Scottish Medicines Consortium also accepted Lytenava™ for use within NHS Scotland in June 2025.

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

On 4 March 2026, CSPC Pharmaceutical Group announced that it has received approval from China’s National Medical Products Administration (NMPA) to begin clinical trials of its emicizumab injection (SYS6053), a biosimilar to Roche’s Hemlibra® (emicizumab), for the treatment of Haemophilia A.  According to CSPC, the product, which is a modified bispecific humanised monoclonal antibody, has been demonstrated to be highly similar to Hemlibra® in terms of quality, safety and efficacy in pharmaceutical and non-clinical studies.  Emicizumab is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with Haemophilia A, with or without factor VIII inhibitors.  Hemlibra® was first approved by the US FDA in November 2017, followed by marketing authorisation from the EMA in February 2018.

CSPC Pharmaceutical Group is a Hong Kong-incorporated pharmaceutical company who has a growing biosimilar portfolio; in August 2025, CSPC received NMPA approval to conduct clinical trials of its biosimilar dupilumab injection (biosimilar to Sanofi/Regeneron’s Dupixent®), and in November 2024, its biologic licence application for biosimilar ustekinumab was accepted by the NMPA.

Biosimilar development of emicizumab is at a very early stage globally.  There are currently no approved emicizumab biosimilars in any major market.  Prestige BioPharma has a preclinical emicizumab biosimilar candidate in development.  The development of biosimilars for emicizumab presents unique challenges due to its bispecific monoclonal antibody structure, which is more complex than traditional monoclonal antibodies.  The patent for Hemlibra® is expected to expire around 2032.  In September 2025, the World Health Organisation (WHO) updated its Model List of Essential Medicines to include emicizumab for Haemophilia A, a development which may help to stimulate further investment in emicizumab biosimilar development.  CSPC’s clinical trial approval for SYS6053 appears to position it among the first companies globally to advance an emicizumab biosimilar into clinical development.

On 3 March 2026, Janssen Biotech Inc and Janssen Sciences Ireland UC filed proceedings against Bio-Thera Solutions and Accord BioPharma in the US District Court for the District of Delaware, alleging infringement of 17 patents related to golimumab.  The Court has granted Janssen’s motion to file the complaint under seal and requires a redacted version to be filed by 11 March 2026. Summons were issued to Accord BioPharma on 4 March 2026, with an answer to the Court due on 25 March 2026.

On 16 July 2025, Bio-Thera announced that the FDA had accepted its BLA for Gotenfiar®(BAT2506), biosimilar to Janssen’s Simponi® (golimumab).  BAT2506 is being developed and manufactured by Bio-Thera and will be commercialised in the US by Intas Pharmaceuticals’ subsidiary, Accord Biopharma, under a February 2025 agreement.

Bio-Thera has entered into the following commercialisation agreements for BAT2506, including with SteinCares for Latin America (March 2024), STADA in Europe, the UK and selected other countries (May 2024), and Dr Reddy’s for South East Asia (March 2025).

In February 2025, Bio-Thera/STADA’s European Marketing Authorisation Application (MAA) for BAT2506 was accepted by the European Medicines Agency (EMA) and in December 2025, it received a positive CHMP opinion.

On 3 March 2026, Moderna entered into a settlement with Arbutus Biopharma and Genevant Sciences to resolve the global COVID patent litigation, including the lengthy dispute in the US District Court for the District of Delaware.  This settlement comes days before the scheduled jury trial on 9 March 2026, which will no longer proceed.

The US litigation commenced on 28 February 2022, when Arbutus/Genevant sued Moderna for alleged patent infringement of six US patents related to the lipid-nanoparticle (LNP) technology used in Moderna’s COVID-19 vaccine, Spikevax®.  The case later expanded to include Moderna’s RSV vaccine, mRESVIA®, which was approved by the FDA in 2024.  In March 2025, Arbutus/Genevant jointly filed five international lawsuits covering 30 countries to enforce patents protecting their LNP technology against Moderna and certain affiliates.

This settlement resolves all litigation worldwide related to Spikevax® (elasomeran) and mRESVIA® vaccines allowing Moderna to develop and supply these vaccines without the risk of further patent disputes between the parties.  Moderna will owe no future royalties under the agreement.

Under the settlement terms, Moderna will make a lump sum payment of $950 million in the third quarter of 2026.  Moderna will also appeal to the US Court of Appeals for the Federal Circuit regarding its potential liability over vaccine sales through government contracts.  If Moderna succeeds on the appeal, no further payment will be required.  However, if Modern is unsuccessful, the company will be required to pay up to $1.3 billion, depending on the scope of the Federal Circuit’s decision, within 90 days of that ruling.  If Moderna prevails with further litigation, Arbutus/Genevant will refund the additional payment with interest.

There has been other ongoing litigation relating to Moderna’s COVID vaccines.  In March 2025,  five lawsuits were commenced in the same week as two US Moderna patents related to Spikevax® were invalidated by the Patent Trial and Appeal Board (PTAB).  The PTAB invalidation followed IPRs filed by Pfizer and BioNTech in 2023 (IPR2023-01358 and IPR2023-01359) against two patents for the Moderna coronavirus vaccine (US10702600 and US10933127) respectively.  According to Pfizer/BioNTech media releases, the decision was delivered by PTAB on 6 March 2025.  Moderna has appealed the PTAB decision to the Federal Circuit.

On 1 March 2026, Australia’s Pharmaceutical Benefits Scheme published its summary of changes.  Among the changes is the expansion of the PBS listing for nivolumab and ipilimumab to enable broader access for the treatment of advanced or metastatic cancers.

The Australian Pharmaceutical Benefits Advisory Committee (PBAC) had recommended a broad, multi-indication PBS listing for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) in advanced or metastatic cancers in September 2025.  The multi-indication PBS-listing of nivolumab and ipilimumab takes effect from 1 March 2026 and is the first of its kind in Australia.

The PBS listing allows clinicians to apply clinical judgment and discretion in using the medicines according to the best available evidence at the time, including for rare cancers for which regulatory submissions are unlikely.  The listing also removes the once in a lifetime limitation for these medicines when used for advanced or metastatic cancers.

On 27 February 2026, Genentech filed a complaint at the US International Trade Commission (ITC) alleging that Biocon’s importation of its pertuzumab biosimilar, BMAB 1500/PERT-IJS infringed four US patents: US8652474 (for pharmaceutical compositions comprising a HER2 antibody and certain acidic variants thereof); US11597776 (methods of making such compositions); US12145997 (methods for preventing reduction of disulfide bonds during an antibody manufacturing process); and US12173080 (related to US’997).  Genentech alleges that on 18 October 2025, Biocon imported more than 17,800 units of BMAB 1500 from India before it received FDA approval.  Genentech contends this conduct falls outside the safe harbour under 35 USC 271(e)(1) (allowing otherwise infringing conduct reasonably related to regulatory submissions) characterizing it as stockpiling of commercial supplies.

Genentech has recently settled US District Court litigation in which the same patents, among others, were alleged to be infringed by Henlius and Organon.

Genentech’s partner, Roche, has previously commenced legal action against a pertuzumab biosimilar in India, suing Zydus for patent infringement in the High Court of New Delhi.

On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its February 2026 meeting, including positive opinions for 6 biosimilars: Shanghai Henlius/Organon’s Poherdy® (HLX11) (pertuzumab), Gedeon Richter’s Tuyory® (tocilizumab), Biocon’s Fubelv® (etanercept), Sandoz/Gan & Lee’s Bysumlog® (insulin lispro) and Dazparda® (insulin aspart), and CinnaGen’s Zandoriah™ (teriparatide).

Shanghai Henlius/Organon’s Poherdy® (HLX11), biosimilar to Genentech/Roche’s Perjeta® (pertuzumab), is indicated for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer.  Under a June 2022 deal, Organon has exclusive global commercialisation rights for Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.  Poherdy® received FDA approval in November 2025 and Henlius/Organon settled BPCIA litigation relating to pertuzumab with Genentech/Roche in January 2026.

Richter’s Tuyory® (RGB-10), biosimilar to Roche’s RoActemra® (tocilizumab) was recommended by CHMP across multiple indications.  Tuyory® was jointly developed by Richter and Mochida Pharmaceutical, with Mochida being responsible for regulatory filings in Japan and Richter filing marketing authorisation applications in other countries.  There are 3 tocilizumab biosimilars approved in Europe: Fresenius Kabi’s Tyenne® (November 2023), STADA’s Tocilizumab STADA™ (previously Biogen’s Tofidence®) (June 2024) and Celltrion’s Avtozma® (February 2025).

Fubelv®, biosimilar to Pfizer’s Enbrel® (etanercept) is Biocon’s second etanercept brand in the EU.  The first, Nepexto® was EU approved in 2020 (with Lupin being the marketing authorisation holder at that time).

Gan & Lee’s Bysumlog®, biosimilar to Eli Lilly’s Humalog® (insulin lispro) and Dazparda®, biosimilar to Novo Nordisk’s Novolog® (insulin aspart), will be commercialised in Europe by Sandoz under a December 2018 agreement.

CinnaGen’s Zandoriah™, biosimilar to Eli Lilly’s Forteo® (teriparatide), will join a number of other teriparatide biosimilars registered in Europe, including Richter’s Terrosa® (approved in 2017).  A previous application for EU approval of a teriparatide biosimilar was withdrawn by CinnaGen in September 2021.

On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for 6 medicines, 3 of which are biopharmaceuticals: Sanofi/Regeneron’s Dupixent®, MSD’s Keytruda® and Janssen’s Stelara®.

Sanofi/Regeneron’s Dupixent® (dupilumab) received a positive recommendation for the treatment of children aged 2 to 11 years with moderate to severe chronic spontaneous urticaria (CSU).  The existing CSU indication in Europe (approved in November 2025) covers adults and adolescents (12 years and above).  According to Regeneron’s press release, an sBLA has been accepted for review in the US seeking approval for Dupixent® in children aged 2 to 11 years with CSU, with a decision expected by April 2026.

The CHMP also recommended indication of MSD’s Keytruda® (pembrolizumab), in combination with paclitaxel (with/without bevacizumab), for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in certain adults.

Janssen’s Stelara® (ustekinumab) received a recommendation for a change to its indication for paediatric Crohn’s disease for children from 2 years of age, from the current indication of paediatric patients weighing at least 40 kg.

Biosimilar launches, approvals and/or development are well underway for each of dupilumab, pembrolizumab and ustekinumab:

• Companies with dupilumab biosimilars in development include Alvotech, Samsung Bioepis, Formycon, Mabwell, Chong Kun Dang. CSPC Pharmaceutical, and Bio-Thera Solutions.
• Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025).  Pembrolizumab biosimilars are also under development including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, BioNTech, Alvotech and Formycon.
• Ustekinumab biosimilars were launched in Europe in July 2024 by STADA/Alvotech (Uzpruvo®) and Sandoz (Pyzchiva®). Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).

On 26 February 2026, Celltrion reported that it plans to expand its biosimilar lineup to 18 products by 2030 with seven candidates that have either entered clinical development or for which investigational new drug applications are being prepared.  Celltrion’s disclosed programmes include CT-P53 biosimilar to Ocrevus (ocrelizumab), CT-P55 biosimilar to Cosentyx (secukinumab) and CT-P52 biosimilar to Taltz (ixekizumab) in autoimmune diseases, as well as cancer therapies CT-P51 biosimilar to Keytruda (pembrolizumab) and CT-P44 biosimilar to Darzalex (daratumumab).

This announcement adds further detail to Celltrion’s commercialisation plans reported in January 2026.

On 25 February 2026, India-headquartered Shilpa Biologics and Costa Rican-based SteinCares announced they have entered into a licensing agreement for commercialisation of an undisclosed biosimilar in Latin America.  

Under the agreement, SteinCares will have exclusive rights to register, commercialise and distribute the biosimilar across Latin America, while Shilpa will be responsible for product development, manufacture and supply to SteinCares.  The collaboration provides Shilpa’s first entry into the Latin American market.  

SteinCares has existing partnerships with companies seeking to commercialise their biosimilars across Latin America.  In June 2025, SteinCares and Bio-Thera entered into an agreement to commercialise biosimilar dupilumab across Latin America, which was the fourth product the companies have collaborated on in the region.