Other Updates

On 23 February 2026, Sandoz announced that the European Commission has approved Ranluspec®, biosimilar to Genentech’s Lucentis® (ranibizumab).  Sandoz is currently planning to launch Ranluspec® in the EU in the second half of 2026.

The EU marketing approval follows a positive CHMP opinion in December 2025 for the biosimilar, which is indicated 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.

Ranluspec® was developed, manufactured and registered by Lupin.  Under an August 2025 agreement between Lupin and Sandoz, Sandoz is responsible for marketing and commercialising the biosimilar across the European Union (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam and Malaysia.  Sandoz is commercialising Epruvy^® (ranibizumab) in Germany under a separate agreement with Formycon/Bioeq.

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).

On 20 February 2026, Dr Reddy’s Laboratories announced that its Biologics Licence Application (BLA) for DRL_AB, biosimilar to BMS’ Orencia® (abatacept), has been accepted for review by the FDA.  Dr Reddy’s expects regulatory approval in the US at the end of 2026 for the IV formulation and in early 2028 for the subcutaneous formulation.

DRL_AB (IV) is proposed for the following indications: adults with moderate to severe active rheumatoid arthritis, active psoriatic arthritis and active polyarticular juvenile idiopathic arthritis in patients aged 6 and above.

In March 2023, Dr Reddy’s entered an exclusive worldwide agreement with Coya Therapeutics, under which Coya is licensed to use Dr Reddy’s abatacept biosimilar to develop and commercialise a subcutaneous combination product, COYA 302 (abatacept with COYA-301, Coya’s low-dose interleukin-2 (IL-2)).

Kashiv Biosciences is also developing biosimilar abatacept, with the successful completion of a phase 1 clinical trial of KSHB002 announced in January 2025.

On 19 February 2026, Outlook Therapeutics announced that it has entered into an exclusive commercial distribution agreement with Mediconsult for Lytenava™ (ONS-5010, bevacizumab-vikg/bevacizumab gamma) in Switzerland.

Under the agreement, Mediconsult has exclusive rights to market, import, distribute, commercialise and maintain regulatory affairs for Lytenava™ in Switzerland, whilst Outlook Therapeutics is responsible for the manufacture and supply of the product.  Outlook Therapeutics expects Lytenava™ to be available in Switzerland in 2027, subject to regulatory approval.

Lytenava™ is the first and only authorised ophthalmic formulation of bevacizumab in the EU and UK.  It received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024.  Lytenava™ was launched in June 2025 in the UK and Germany for treatment of wet AMD.  The Scottish Medicines Consortium accepted Lytenava™ for use within NHS Scotland in June 2025.

Outlook Therapeutics received a Complete Response Letter (CRL) from the FDA in December 2025 following a second resubmission of its Biologics Licence Application for Lytenava™.  On 11 February 2026, Outlook Therapeutics announced that it had submitted a Type A meeting request with the FDA.

There is at least one ophthalmic bevacizumab biosimilar under development.  In March 2025, Intas Pharmaceuticals received approval from India’s CDSCO to conduct Phase 2/3 trials for bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

On 19 February 2026, Zydus announced the Indian launch of Anyra™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2 mg.  Anyra™ is the first aflibercept 2mg biosimilar developed in India and is launched under licence from Regeneron and Bayer.

Anyra™ is approved for the treatment of wet age-related macular degeneration, diabetic retinopathy, visual impairment due to macular oedema following retinal vein occulsion, diabetic macular oedema and myopic choroidal neovascularisation.

Zydus’ Indian developed and manufactured biosimilar portfolio includes more than 13 biosimilars and complex biologics.

There is at least one other aflibercept biosimilar set to launch in India in 2026.  In September 2025, Biocon’s Yesafili®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg, was recommended by India’s Subject Expert Committee (SEC).  This recommendation was subject to Biocon submitting a Phase IV clinical trial protocol to the CDSC within 3 months of obtaining the marketing authorisation grant.  In January 2026, Biocon Biologics reached a settlement and licence agreement with Regeneron and Bayer for Yesafili® in Europe and ROW, which permits Biocon to commercialise Yesafili® in India (and ROW other than UK, US and Canada) in H2 2026.

On 18 February 2026, Sandoz announced that the FDA has approved an indication extension for Enzeevu®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg, to include macular oedema following retinal vein occlusion, diabetic retinopathy and diabetic macular oedema.  Enzeevu® was approved by the FDA for nAMD in August 2024.

Enzeevu® has not yet launched in the US.  Under a settlement entered into with Regeneron, announced in September 2025, Sandoz is permitted to launch Enzeevu® in the US in Q4 2026, or earlier in certain undisclosed circumstances.

The only biosimilar aflibercept currently on the market in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  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), 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, subject to regulatory approval).

On 17 February 2026, MSD announced that Health Canada has approved Keytruda SC™ (pembrolizumab), a subcutaneous (SC) formulation of pembrolizumab injection for multiple cancer indications.

The Canadian approval follows European approval of Keytruda SC™ in November 2025, after a positive recommendation from the EMA’s CHMP in September 2025.  However, in December 2025, the Munich Regional Court granted a preliminary injunction to Halozyme, preventing MSD from distributing and offering for sale in Germany Keytruda SC™.  The decision was based on a finding of the Court that there was imminent infringement of one of Halozyme’s European MDASE™ patents, EP 2797622, in relation to modified PH20 hyaluronidase polypeptides and compositions.

MSD’s subcutaneous formulation of pembrolizumab was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications.  Halozyme has also sued MSD in the US in relation to SC pembrolizumab.

While there are no reports as yet of biosimilar subcutaneous pembrolizumab, there are multiple pembrolizumab biosimilars approved or in development.  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 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 Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.  Formycon has announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region, Zydus Lifesciences for the US and Canada, and Lotus for the Asia-Pacific.

On 17 February 2026, Accord BioPharma announced it has received FDA approval for Filkri™, biosimilar to Amgen’s Neupogen® (filgrastim), for the same indications as the reference medicine.

There are multiple filgrastim biosimilars that have been approved by the FDA since Sandoz’s Zarxio® was first approved in March 2015, including Hospira’s Nivestym™ (filgrastim-aafi) (July 2018), Kashiv Biosciences/Amneal’s Releuko™ (filgrastim-ayow) (March 2022), and Tanvex BioPharma’s Nypozi™ (filgrastim-txid) (July 2024).

On 16 February 2026, Shanghai Henlius Biotech announced it has obtained Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its subcutaneous daratumumab biosimilar, HLX15-SC.  This will allow Henlius to undertake a phase I clinical study of HLX15-SC, biosimilar to J&J’s Darzalex Faspro® (daratumumab and hyaluronidase-fihj), for the first-line treatment of multiple myeloma.

The FDA clearance follows Henlius’ announcement on 12 February 2026 that China’s National Medical Products Administration (NMPA) approved a Phase 1 trial of HLX15-SC.

Henlius is also developing an IV form of HLX15, having completed a Phase 1 clinical trial of HLX15-IV in June 2024.  The trial demonstrated similar pharmacokinetic characteristics, comparable safety and immunogenicity profiles of HLX15-IV to the US, EU and CN-sourced Darzalex® (daratumumab).

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

Henlius’ development appears to be trailing that of Celltrion.  In September 2025, the European Medicines Agency approved Celltrion’s IND application for its global Phase 3 clinical trial of CT-P44 (daratumumab), following approval of its US IND submission in December 2024.  In December 2025, CSPC Pharmaceutical Group obtained approval from the NMPA to conduct clinical trials in China of its Daratumumab Injection.

In August 2025, BIOCAD announced that the Russian Ministry of Health had approved its Daratumia®.  This was the first reported regulatory approval for a daratumumab biosimilar worldwide.

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”.