Other Updates

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

On 5 March 2026, J&J announced the US approval of Tecvayli® (teclistamab-cqyv) in combination with Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of relapsed or refractory multiple myeloma (RRMM) as a second line treatment.

This approval was based on the Phase 3 MajesTEC-3 study, which evaluated the safety and efficacy of teclistamab and daratumumab in RRMM patients who had received at least one prior line of therapy, against the one of the following combinations:

• daratumumab, dexamethasone and pomalidomide or
• daratumumab, dexamethasone, bortezomib

The Tecvayli®/Darzalex Faspro® combination demonstrated the best patient outcomes, showing an 83% reduction in the relative risk of progression or death when compared with standard treatment.

Approval was granted 55 days after filing, following the selection of the teclistamab’s sBLA under the Commissioner’s National Priority Voucher Pilot Program.

Daratumumab biosimilars are under development by Celltrion, Henlius, and CSPC.  Globally, the first approval for a daratumumab biosimilar was granted in Russia to Biocad in August 2025.  There is no evidence that any teclistamab biosimilars have been submitted for regulatory review or approval.

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.