Other Updates

On 13 December 2025, Biocon Biologics announced that it has reached a settlement and licence agreement with Regeneron and Bayer for Yesafili®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in Europe and ROW, enabling Biocon to launch Yesafili® in the UK in January 2026 and ROW in March 2026, or earlier under certain undisclosed circumstances.  The settlement follows an April 2025 settlement between the companies covering the US and Canada, which paves the way for a US launch of Yesafili® in H2 2026.

Yesafili® was the first aflibercept biosimilar to receive European marketing approval in September 2023, following a positive CHMP opinion in July 2023.  It was approved in the UK in November 2023.

Sandoz’s Afqlir® was the first aflibercept biosimilar to launch in the UK on 24 November 2025, following the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept).  At the time, Sandoz announced the launches in major European markets such as Germany and France would follow, with additional European rollouts to occur in 2026.

Other aflibercept biosimilars currently approved in Europe include Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025).

Litigation will continue to hold up European launches for some biosimilar sponsors.  For example, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction preventing Formycon’s launch of its aflibercept biosimilar in 20 countries.  The Hague District Court also granted an injunction in October 2025 preventing Samsung Bioepis from launching its aflibercept biosimilar in the Netherlands.

The news has been better for aflibercept biosimilars in the UK, with Samsung Bioepis and Formycon/Klinge defeating injunction applications by Regeneron/Bayer in relation to their aflibercept biosimilars in October 2025.  In early November 2025, the UK High Court rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s Mynzepli®.

On 12 December 2025, Celltrion announced that it has successfully secured reimbursement coverage for Avtozma® IV, biosimilar to Roche’s Actemra® (tocilizumab), in the US, having signed a listing agreement with Synergie Collective, one of the top five prescription drug benefit managers (PBMs) in the United States.

Patient reimbursement for Avtozma® IV will be available from January 2026, and has been designated as a preferred drug for priority prescriptions in all public and private insurance formularies managed by Synergy.

Avtozma® was the third tocilizumab biosimilar approved in the US (January 2025), and was subsequently launched in an IV formulation in October 2025.  Biogen/Bio-Thera’s Tofidence®/BAT1806 was the first US approved tocilizumab biosimilar (IV formulation, September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (SC formulation, March 2024; IV formulation launched April 2024; SC formulation launched July 2024).

In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence® in June 2024.

Avtozma® has been granted marketing authorisation in a number of other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025), Japan (September 2022) and New Zealand (December 2025), and was considered for listing on Australia’s PBS at PBAC’s November 2025 meeting (outcomes from that meeting are yet to be published).

On 12 December 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its December 2025 meeting, including positive opinions for two biosimilars.

Bio-Thera/STADA’s Gotenfia® (BAT2506), biosimilar to Janssen’s Simponi® (golimumab), was recommended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis.

Gotenfia®/BAT2506 was developed by Bio-Thera and is being commercialised by STADA in Europe under a May 2024 agreement.  Alvotech/Advanz’s Gobivaz® was the first golimumab biosimilar approved in Europe last month (November 2025).

A positive CHMP opinion was also adopted for Lupin’s Ranluspec®, biosimilar to Genentech’s Lucentis® (ranibizumab), for the treatment of nAMD, visual impairment due to DME, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularisation.

Under an August 2025 agreement, Lupin has partnered with Sandoz, which will market and commercialise Lupin’s ranibizumab biosimilar across the European Union (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam and Malaysia.

Samsung Bioepis’ Byooviz® (ranibizumab) was the first ophthalmology biosimilar approved in Europe in August 2021 (in vial form) and has been commercially available in several European countries since March 2023.  On 2 December 2025, Samsung Bioepis announced that the CHMP had adopted a positive opinion for Byooviz® in pre-filled syringe (PFS) form.  Other ranibizumab biosimilars previously approved in Europe include Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva and STADA/Xbrane’s Ximluci® (approved November 2022).

At its December 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for a number of biopharmaceuticals.

Among these, Regeneron/Bayer’s Eylea® 8mg (aflibercept) 114.3 mg/ml solution for injection) was recommended for the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO).  Once approved by the European Commission, this will be the third indication for the high dose form of Eylea®, which was previously approved in the EU in January 2024 for treatment of nAMD and diabetic macular oedema.  Eylea HD® (as the 8mg product is known in the US) was FDA approved for the RVO indication in November 2025.

Alvotech is developing AVT29, a biosimilar to Regeneron’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.

This month, the CHMP has also adopted a positive opinion for Janssen’s Simponi® (golimumab), for the treatment of paediatric ulcerative colitis.  The CHMP decision follows the FDA’s approval of the same indication in October 2025.

Alvotech/Advanz’s Gobivaz® was the first and only EU golimumab biosimilar approved in Europe in November 2025.  However, Bio-Thera/STADA’s Gotenfia®/BAT2506 is following closely behind, with a positive CHMP opinion for the biosimilar adopted at the December 2025 EMA meeting.

Other biopharmaceuticals to receive CHMP recommendations at the December 2025 meeting are:

• GSK’s Nucala® (mepolizumab), for chronic obstructive pulmonary disease (COPD); and
• Amgen’s Uplizna® (inebilizumab), for neuromyelitis optica spectrum disorders (NMOSD).

On 11 December 2025, Bristol Myers Squibb announced that the FDA has granted priority review to its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine chemotherapy for adult and paediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL).  The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 8 April 2026.

Recent new indication approvals for Opdivo® have generally been for treatments in combination with Yervoy® (ipilimumab) including for:

• Colorectal cancer in Australia, Canada, Europe, Japan, USA; and
• Hepatocellular carcinoma in Canada, Europe, Japan, Korea, Taiwan,

Previous approvals in combination with chemotherapy include for:

• Non-small cell lung cancer in Australia, Europe, USA;
• Urothelial carcinoma in Taiwan, USA; and
• Gastric, gastroesophageal junction or oesophageal adenocarcinoma in

A number of nivolumab biosimilars are under development including Xbrane/Intas’ Xdivane, Amgen’s ABP 206, Reliance Life Science’s RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.  In August 2025, Sandoz wound down its Phase III trial of JPB898 as a measure to streamline its biosimilar nivolumab development program following feedback from regulatory authorities regarding requirements for biosimilar approvals.

On 10 December 2025, Polpharma Biologics announced that it has entered a licence agreement with Brazilian pharmaceutical company, Libbs Farmacêutica, for the commercialisation of an unnamed biosimilar for autoimmune diseases in Brazil.

Under the agreement, Polpharma retains responsibility for the development and manufacturing of the biosimilar, while Libbs has exclusive rights for the commercialisation, marketing and distribution of the product in Brazil.

The deal between Polpharma and Libbs follows a licensing agreement between Polpharma and MS Pharma in September 2025 for the commercialisation in the MENA region of biosimilars to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®).  In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).

On 10 December 2025, Zydus Lifesciences announced the Indian launch of Zyrifa™ (denosumab 120mg SC), biosimilar to Amgen’s Xgeva® (denosumab).

The launch of Zydus’ denosumab biosimilar in India follows a flurry of European denosumab biosimilar launches on 1-2 December, including Sandoz’s Jubbonti® and Wyost®, Fresenius Kabi’s Conexxence® and Bomyntra®, Zentiva’s Zadenvi®, Accord Healtcare’s Osvyrti® and Jubereq® and Samsung Bioepis’ Xbryk™ (available from December 2025).

Denosumab biosimilars launched in the US include Sandoz’s Jubbonti® and Wyost® (June 2025), Celltrion’s Stoboclo® and Osenvelt® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025), and Biocon’s Bosaya™ and Aukelso™ (October 2025).

In August 2025, it was reported that India’s Central Drugs Control Organisation (CDSCO) had reviewed and accepted without objection a final Clinical Study Report submitted by Intas Pharmaceuticals for its proposed denosumab biosimilar.

On 9 December 2025, Formycon and Zydus Lifesciences announced that they have entered into an exclusive licensing and supply agreement for the commercialisation of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in the US and Canada.

Under the agreement, Formycon will have responsibility for preparing and filing the regulatory dossier and supplying FYB206, while Zydus will commercialise the product in the US and Canada.  The deal will provide Formycon with an upfront payment in the mid-teens of millions of euros and eligibility for milestone payments in 2025, plus further payments linked to development and regulatory milestones, expected to be in the mid to double-digit millions of euros range.  Formycon will also share in the gross profits generated by sales of the product.

The deal marks Zydus’ entry into the US biosimilar market.  It follows quickly behind Formycon’s agreement with MS Pharma for the commercialisation of FYB206 in the MENA region, announced on 4 December 2025.

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.

Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025 under the name Pembrolizumab Bioéticos.  In November 2025, Biocad’s Pembroria™ (pembrolizumab) was reportedly approved in Vietnam.  A number of other pembrolizumab biosimilars are currently in clinical trials, 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 biosimilar to Keytruda®.

On 8 December 2025, Celltrion announced that it intends to expand its biosimilar pipeline by “internalising” hyaluronidase-based subcutaneous delivery (SC) formulation technology.  According to Celltrion, its SC technology involves temporarily decomposing hyaluronic acid present in subcutaneous tissues to facilitate drug diffusion.

Celltrion’s announcement states that it has been conducting clinical trials for Herzuma® SC (CT-P6 SC), biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™) since February 2025 and plans to submit applications for approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.

Herzuma® was launched in Europe in 2018 and in the US in March 2020.

Celltrion developed the world’s first subcutaneous injection of infliximab, Remsima SC®/Zymfentra®, which was launched in Europe in 2020 and in the US in 2024.

On 8 December 2025, GxP News reported that Russia’s Binnopharm Group and China’s Mabwell have signed a MOU in relation to localising the production of Mabwell’s biosimilar to Regeneron/Sanofi’s Dupixent® (dupilumab) in Russia and the EAEU.

The two companies have previously partnered in 2022, with Binnopharm Group obtaining the exclusive rights for the production, registration and sale of Mabwell’s adalimumab and denosumab biosimilars (9MW0113, 9MW0321 and 9MW0311) in Russia and the EAEU.  In January 2024, Mabwell’s adalimumab and denosumab biosimilars were approved for Phase III clinical trials in Russia, where Russian clinical data is required for local marketing, with Binnopharm to conduct and fund the trials.

There are a number of dupilumab biosimilars under development.  A November 2025 report from Korean news outlet, The Asia News Daily, suggests that Samsung Bioepis is developing a dupilumab biosimilar.  In August 2025, CSPC Pharmaceutical 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.

Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries, with Alvotech responsible for development, and Advanz responsible for commercialisation.