Other Updates

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, 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 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.  

On 25 February 2026, Jiuyuan Genetic Biopharmaceutical announced in a filing with the Hong Kong Stock Exchange that China’s National Medical Products Administration (NMPA) has accepted for review its marketing authorisation application for Jikeqin®, a generic version of Novartis’ Wegovy® (semaglutide).  Jikeqin® is intended for weight management in individuals with obesity or who are overweight.

A phase III clinical trial of Jikeqin®, approved in China in January 2024, has been completed and Jiuyuan Genetic has submitted the results to the Center for Drug Evaluation of NMPA for review.

Generic versions of Wegovy® are in development by a number of companies.  In January 2026, it was reported that Sun Pharmaceutical, Zydus Lifesciences and Alkem Laboratories had received approval in India to manufacture and sell generic versions of Novartis’ Wegovy® and Ozempic®.  According to Zydus, it plans to launch its Semaglutide Injection (15mg/3ml) in India under the brand names Semaglyn™, Mashema™ and Alterme™ “upon semaglutide patent expiry”.

In July 2025, it was reported that Dr Reddy’s plans to launch its generic version of Wegovy® in 87 countries in 2026, beginning with Canada, India, Brazil, Turkey and other emerging markets, subject to patent expiry.  According to a February 2026 report, Dr Reddy’s is hoping to launch the generic in India at a price that could be up to 60% lower than Novartis’ Wegovy®.

Health Canada is reviewing 9 submissions for generic semaglutide, including applications by Sandoz, Apotex, Teva, Aspen Pharmacare and Taro Pharmaceuticals.  It was reported in September 2024 that Sandoz was planning a 2026 generic semaglutide launch in Canada.  Novo Nordisk’s semaglutide patent has expired in Canada and regulatory exclusivity expired in January 2026.

On 25 February 2026, Formycon and Zydus announced positive results from the phase 1 pharmacokinetic study (“Dahlia”) for FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab).  The study, commenced in June 2024, is reported to have met its primary objective and demonstrated bioequivalence of FYB206 and Keytruda®.

The study is part of a streamlined clinical strategy agreed by Formycon with the FDA in relation to FYB206.  In February 2025, Formycon announced it would terminate a Phase 3 trial of FYB206, which commenced in June 2024 as it was no longer necessary for FDA approval.  Instead, Formycon intends to rely on data from the “Dahlia” trial, combined with a comprehensive analytical program to support its regulatory applications, with the aim of making FYB206 available “as soon as possible after the exclusivity” of Keytruda® expires.

Zydus has the exclusive rights to commercialise FYB206 in the US and Canada under an agreement with Formycon announced in December 2025.  Zydus is hoping to be the first to file a Biologics Licence Application for biosimilar pembrolizumab in the US.  Formycon has also recently announced FYB206 commercialisation agreements with MS Pharma (for the MENA Region) and Lotus Pharmaceutical (for parts of Asia Pacific).

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 in clinical trials include Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Bio-Thera’s BAT3306 (integrated PhI/III trial commenced, Ph 3 terminated July 2025 due to regulatory developments), Celltrion’s CT-P51 (Ph 3 trial approved by FDA in August 2024, initiated January 2025), Sandoz’s GME751 (Ph 1 commenced in May 2024, estimated completion July 2026), mAbxience’s MB12 (Ph 3 study commenced December 2024, estimated completion June 2026), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024, expected completion September 2026) and Shanghai Henlius’ HLX17 (approval for clinical trial received September 2024).  Biocon and Alvotech have pembrolizumab biosimilars in their pipelines.

Bayer’s Eylea™ 8mg has received approval in both the UK (reported 25 February 2026) and Korea (reported 27 February 2026) for an expanded indication to include macular oedema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion.  RVO is the third indication for Eylea™ 8mg in both the UK and Korea, in addition to nAMD and DME.

Eylea™ 8mg has also received Korean approval to extend the dosing interval from a minimum of 4 weeks to a maximum of 24 weeks and to shorten the minimum maintenance treatment interval from 8 weeks to 4 weeks.

Eylea™ 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

High dose Eylea® was FDA approved for the RVO indication in November 2025 and received European Commission approval for the same indication extension in January 2026.  Eylea™ 8mg is also approved for nAMD and DME (as intravitreal injection) in multiple other countries, including Japan (January 2024) and Australia (June 2024).  Eylea™ 8mg pre-filled syringe (OcuClick) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).  Regeneron/Bayer have submitted marketing authorisation applications for Eylea™ 8mg for the RVO indication in countries including Japan (May 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron/Bayer’s Eylea™ 8mg.  In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe.  Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US.

Biosimilars of Regeneron/Bayer’s Eylea® 2mg (aflibercept, 2mg) are already on the market around the world, including, for example, Alvotech’s Mynzepli® (launched in the UK, Canada and Japan), Amgen’s Pavblu® (available in the US), Sandoz’s Afqlir®/Enzeevu® (launched in the UK, Australia and Canada), Samsung Bioepis’ Afilivu®/Opuviz® (available in Korea) and Celltrion’s Eydenzelt® (launched in the UK and Europe).

On 24 February 2026, Sana Pharma announced that Pembrava™, biosimilar to MSD’s Keytruda® (pembrolizumab), has been registered by the Jordan Food and Drug Administration for cancer treatment.  Sana Pharma claims that Pembrava™ is the first biosimilar for cancer treatment in Jordan.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025).  There are a number of pembrolizumab biosimilars in clinical trials including Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Bio-Thera’s BAT3306 (integrated PhI/III trial commenced, Ph 3 terminated July 2025 due to regulatory developments), Celltrion’s CT-P51 (Ph 3 trial approved by FDA in August 2024, initiated January 2025), Formycon’s FYB206 (Ph 1/3 trial commenced June 2024 in melanoma), Sandoz’s GME751 (Ph 1 commenced in May 2024, estimated completion July 2026), mAbxience’s MB12 (Ph 3 study commenced December 2024, estimated completion June 2026), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024, expected completion September 2026) and Shanghai Henlius’ HLX17 (approval for clinical trial received September 2024).  Biocon and Alvotech have pembrolizumab biosimilars in their pipelines.

On 24 February 2026, Ono Pharmaceutical announced that the Korean Ministry of Food and Drug Safety has granted additional approval of Opdivo® (nivolumab) intravenous infusion in combination with Yervoy® (ipilimumab), for the treatment of adults with unresectable or metastatic microsatellite instability-high (MSI-High) or mismatch repair deficient (dMMR) colorectal cancer (CRC).  This combination was previously approved in Korea for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (July 2025).

In 2011, Ono granted BMS commercialisation rights for Opdivo® excluding in Japan, South Korea and Taiwan, where Ono retains all rights.  In July 2014, Ono and BMS agreed to expand their collaboration agreement to jointly develop and commercialise multiple immunotherapies as single agent and combination regimens for cancer in Japan, South Korea and Taiwan.

The combination of Opdivo® and Yervoy® has also been approved for colorectal cancer in EU (December 2024), US (April 2025), Australia (June 2025), Canada (August 2025) and Taiwan (January 2026).

Zydus Lifesciences recently successfully opposed BMS’s final appeal in seeking a preliminary injunction in India against Zydus’ nivolumab biosimilar, Tishtha®, the first nivolumab biosimilar in the world to reach market.  At least Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars on the market or in development.  Ipilimumab biosimilars are also on their way, with Sandoz and Shanghai Henlius Biotech announcing a global collaboration agreement for an ipilimumab biosimilar in April 2025.

On 24 February 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for treating adults and children aged 6 years and older with fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery.  Dupixent® is the first and only treatment approved for AFRS in the US.

There are a number of companies with dupilumab biosimilars under development.  For example, Alvotech is developing AVT19 (dupilumab), and has entered into partnership agreements with Advanz in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries.

In January 2026, it was announced that Samsung Bioepis had added a dupilumab biosimilar to its pipeline.  In the same month, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab). CSPC Pharmaceutical had earlier announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.

In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.  It was also reported in December 2025 that Russia’s Binnopharm Group and China’s Mabwell signed a MOU in relation to localising the production of Mabwell’s dupilumab biosimilar in Russia and the EAEU.