Other Updates

On 13 February 2026, STADA and Bio-Thera Solutions announced that the European Commission has granted marketing authorisation for Gotenfia®, biosimilar to Janssen’s Simponi® (golimumab).  According to the announcement, plans are underway to launch Gotenfia® in Europe “in the coming weeks and months”.

Gotenfia® received a positive recommendation from the EMA’s CHMP in December 2025 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis.  It is the second golimumab biosimilar to be approved in Europe, following the approval of Alvotech/Advanz’s Gobivaz® in November 2025.

Gotenfia®/BAT2506 was developed by Bio-Thera and is being commercialised by STADA in Europe under a May 2024 agreement.

On 12 February 2026, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) updated its March 2026 agenda (first published in November 2025) to include consideration for reimbursement of Amgen’s Wezlana®, biosimilar to Janssen’s Stelara® (ustekinumab).

In April 2024, the PBAC recommended  Wezlana® for listing on the Pharmaceutical Benefits Scheme (PBS).  However, Amgen did not proceed with the listing at that time.  Amgen has now come back to the PBAC for consideration of PBS listing of Wezlana® in March 2026.

Wezlana® joins Sandoz’s ustekinumab biosimilar, Ardelya®, on the March 2026 PBAC Agenda, although Ardelya® has not yet received marketing approval in Australia.  Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025.  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.

On 12 February 2026, Pharmacy Daily announced that Arrotex Pharmaceuticals and Pfizer Australia have entered into a commercial partnership for Enbrel® (etanercept) in Australia.  Under the agreement, Arrotex will be responsible for representing Pfizer’s Enbrel® across Australian pharmacies, hospital, and prescriber channels.

Enbrel® is approved for arthritis and psoriasis indications and was listed on the PBS in June 2003.  There are multiple etanercept biosimilars in the Australian market listed on the PBS, including Sandoz’s Erelzi® (approved November 2017, PBS-listed as of October 2025), Biocon Biologics’ Nepexto® (launched in July 2025, PBS-listed as of July 2025) and Samsung Bioepis’ Brenzys®, which was previously distributed in Australia by Arrow Pharmaceuticals (approved by TGA in July 2016, PBS-listed as of April 2017).

In May 2022, Pfizer sued Samsung Bioepis and other companies involved in the commercialisation of Brenzys® in Australia, including Arrow Pharmaceuticals, for alleged infringement of AU 2005280034 (expired September 2025), relating to the production of etanercept.  Samsung Bioepis and Organon (currently named in the Brenzys® Product Information as the Australian distributor) cross-claimed alleging that the AU 034 patent is invalid.  A hearing took place in September and October 2025, with the judgment yet to be delivered by the Federal Court of Australia.

On 12 February 2026, Zhitong Finance reported that Shanghai Henlius Biotech has obtained approval from China’s National Medical Products Administration (NMPA) for a Phase 1 trial of its subcutaneous daratumumab biosimilar, HLX15-SC.

This follows Henlius’ completion of a Phase 1 clinical trial for the IV formulation of HLX15 in June 2024.  That trial demonstrated similar pharmacokinetic characteristics and comparable safety and immunogenicity profiles of HLX15 to the US, EU and CN-sourced reference product, J&J’s Darzalex® (daratumumab).

In February 2025, Henlius announced that it had entered into a licence agreement with Dr Reddy’s for commercialisation of HLX15, covering both subcutaneous and intravenous formulations, across 42 European countries and the United States.

The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025, with approval by the Russian Ministry of Health of Daratumia®.  There are also other daratumumab biosimilars under development.  In December 2025, CSPC Pharmaceutical Group obtained approval from the NMPA to conduct clinical trials in China of its Daratumumab Injection.  In September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44.

On 12 February 2026, Samsung Bioepis announced that it has entered a settlement and licence agreement with Regeneron in relation to commercialisation of Opuviz™ (SB15), biosimilar to Regeneron’s Eylea® (aflibercept), in the US.  Under the terms of the agreement, Samsung Bioepis can launch Opuviz™ (US approved in May 2024) in the US from January 2027.

The settlement resolves BPCIA litigation pending between the companies.  On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching Opuviz™ in the US without a licence from Regeneron.  This affirmed an earlier decision in June 2024 (US District Court -Northern District of West Virginia), finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.

In January 2026, the companies struck an EU/ROW deal permitting launch of SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement (excluding Korea where it is already on the market) from May 2026.

Only a single biosimilar competitor to Regeneron’s Eylea® is currently on the market in the US; Amgen’s Pavblu®, launched October 2024.  However, there are a number of approved aflibercept biosimilars, some of which have scheduled 2026 launch dates as a result of litigation settlements: Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026), Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026), and Alvotech/Teva’s AVT06 (BLA accepted for review February 2025, due to launch Q4/2026).

On 11 February 2026, Celltrion announced that it received approval from the European Medicines Agency (EMA) to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab).  Celltrion expects this approval to shorten the overall clinical timeline and to reduce development expenses for CT-P55.

The Phase 3 trial is designed to evaluate the efficacy, safety and equivalence of CT-P55 in comparison to Consentyx® in patients with plaque psoriasis.  The FDA approved the global Phase 3 trial in August 2024.  Celltrion presented results from its Phase 1 trial for CT-P55 in September 2025.

Other secukinumab biosimilars in development include Bio-Thera’s BAT2306 (Phase 1 trial completed in 2023, Phase 3 clinical trial completed in 2024; commercialisation agreement with Dr Reddy’s in November 2025), Taizhou Mabtech Pharmaceutical’s CMAB015 (Phase 1 completed in 2023) and Livzon Pharmaceutical Group’s LZM012 (Phase 3 clinical trial, status unknown).

On 11 February 2026, the Supreme Court of India dismissed the Special Leave Petition of BMS requesting an appeal from the decision of the High Court of Delhi appellate division that allowed Zydus to launch its low cost nivolumab biosimilar, Tishtha®, pending resolution of the infringement claim brought by BMS.  The Supreme Court has also ordered Zydus to provide a sample of its product to BMS for mapping against its patent claims.

Zydus launched Tishtha® in India on 22 January 2026, just over a week after the first instance High Court decision.  The biosimilar had received regulatory approval in India in July 2024 and is the first nivolumab biosimilar in the world to reach the market.  In India, Tishtha® is priced at about one quarter the cost of BMS’ Opdivo®/Opdyta®.

BMS’ Court loss will be encouraging to other companies with nivolumab biosimilars in the pipeline aimed at the Indian market, such as Enzene and Reliance Life Sciences.  Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius and Biocon also have nivolumab biosimilars under development.

On 11 February 2026, Formycon and Taiwan-based Lotus Pharmaceutical announced they have concluded an exclusive licence agreement in relation to the commercialisation of Formycon’s FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in major parts of the Asia-Pacific region.

Under the agreement, Formycon will be responsible for manufacturing and supplying the pembrolizumab biosimilar, with both companies “closely aligning” to prepare regulatory submissions in the relevant APAC countries.  Formycon will receive an upfront payment upon execution of the agreement, and further payments depending on the achievement of development and regulatory milestones.  Formycon will also receive a share of the gross profits upon launch of the product in the licensed countries.

This is the third agreement Formycon has concluded recently in relation to FYB206.  In December 2025, Formycon announced agreements with MS Pharma for the MENA region and Zydus Lifesciences for the US and Canada.

Formycon commenced an integrated Ph1/3 study in June 2024 to demonstrate PK similarity of FYB206 with Keytruda® in patients with Stage IIB/IIC or Stage III melanoma.  On 10 July 2025, Formycon announced that it had completed patient enrolment.  Formycon expects results to be available in Q1 2026.  Formycon had originally intended to conduct a parallel Phase 3 trial to compare the safety and efficacy of FYB206 with Keytruda® in NSCLC.  However, in February 2025, Formycon announced the premature termination of the “Lotus” Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.

A pembrolizumab biosimilar has 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 and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar in Saudi Arabia/MENA.

Formycon/Klinge and Lotus have previously partnered (February 2025) in relation to FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in the following Asia-Pacific countries: Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam and Hong Kong.

During its Q3 FY26 Earnings Call on 10 February 2026, Zydus Lifesciences indicated that it is hoping to be the first to file a Biologics Licence Application in the US for a pembrolizumab biosimilar and may potentially be first to launch in the US, subject to regulatory approvals.

The optimism comes after Zydus entered into an exclusive licensing and supply agreement with Formycon in December 2025 for the commercialisation of Formycon’s FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in the US and Canada.  According to Zydus, Formycon is “the furthest ahead in terms of the clinical development and FDA guidance” in relation to biosimilar pembrolizumab.

Formycon commenced an integrated Ph1/3 study in June 2024 to demonstrate PK similarity of FYB206 with Keytruda® in patients with Stage IIB/IIC or Stage III melanoma.  On 10 July 2025, Formycon announced that it had completed patient enrolment.  Formycon expects results to be available in Q1 2026.  Formycon had originally intended to conduct a parallel Phase 3 trial to compare the safety and efficacy of FYB206 with Keytruda® in NSCLC.  However, in February 2025, Formycon announced the premature termination of the Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.

Other pembrolizumab biosimilars in clinical trials include Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024, initiated January 2025), Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024), Sandoz’s GME751 (Ph 1 commenced in May 2024), Henlius’ HLX17 (approval for clinical trial received September 2024), and mAbxience’s MB12 (Ph 3 study commenced December 2024).

On 5 February 2026, Korea Biomedical Review reported that Korean headquartered HK inno.N has received approval from Korea’s Ministry of Food and Drug Safety for Izambia Prefilled Syringe and Denbrayce Injection, biosimilars to Amgen’s Prolia® and Xgeva® respectively.

HK inno.N entered an exclusive licence agreement with mAbxience in January 2023 for the commercialisation of the denosumab biosimilars.  mAbxience’s Izamby® and Denbrayce® received European approval in July 2025.

Celltrion’s Stoboclo® and Osenvelt® were the first denosumab biosimilars to be approved in Korea (November 2024).  In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®.  Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.  Boryung launched Samsung Bioepis’ Xbryk® on 1 August 2025, following its regulatory approval in May 2025.  Samsung Bioepis and Hanmi Pharmaceuticals announced their joint South Korean launch of Samsung Bioepis’ Obodence™ (reference: Prolia®) in July 2025.