On 24 November 2025, Sandoz announced the UK launch of Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), with launches in major European markets such as Germany and France to follow, and additional European rollouts to occur in 2026.

Afqlir® was the second aflibercept biosimilar approved in Europe in November 2024 and received marketing authorisation in the UK in January 2025.  It is approved for all indications of Eylea® and is available in a 2 mg vial kit and pre-filled syringe for intravitreal injection.

The European launch of Afqlir® follows the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept).  It is expected that other European aflibercept biosimilar launches will be announced shortly.

Aflibercept biosimilars currently approved in Europe include Biocon’s Yesafili® (September 2023), 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).  Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.

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 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s antibody-drug conjugate Enhertu® (trastuzumab deruxtecan).  According to the report, the biosimilar is still in the early development stage, in preparation for preclinical trials.

The report also suggests that Samsung Bioepis is developing biosimilars to MSD’s Keytruda® (pembrolizumab), Regeneron/Sanofi’s Dupixent® (dupilumab), Janssen’s Tremfya® (guselkumab) and Eli Lilly’s Talz® (ixekizumab).  Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) on 5 April 2024.  Samsung Bioepis has not issued press releases to date in relation to the development of any of the other biosimilars referred to in The Asia News Daily report.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Daiichi Sankyo is solely responsible for manufacturing and supply.

On 20 November 2025, Formycon and Bioeq jointly announced that their commercialisation partner, Sandoz, has launched Epruvy®, biosimilar to Genentech’s Lucentis®, in Germany.  Sandoz is marketing the product, which is indicated for nAMD, macular oedema, diabetic retinopathy and other visual impairments, under licence from Bioeq, a joint venture between Formycon and Polpharma Biologics.

Epruvy® was approved by the European Medicines Agency in September 2024 (as Ranibizumab Midas), following a positive CHMP opinion in July 2024, and is available in vial and pre-filled syringe (PFS) dosage forms.  According to Formycon, the PFS is a “first-of-its kind ophthalmic biosimilar presentation in Germany”.

Formycon/Teva’s Lucentis® biosimilar, FYB201/Ranivisio®, was first approved in Europe in August 2022 and has been commercialised in the region in vial form by Teva since 2022.  In October 2025, Formycon/Teva announced the launch of the PFS form in France, with additional countries to follow in a staggered approach.  FYB201 was approved in the UK in May 2022 (marketed as Ongavia® by Teva), the US in August 2022 (marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), Canada in December 2023 (marketed as Ranopto™ by Teva) and MENA in March 2024 (marketed as Ravegza® by MS Pharma).

Other approved ranibizumab biosimilars in Europe include Samsung Bioepis’ Byooviz® (EU-approved in September 2021); Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (EU-approved 9 November 2022).

On 20 November 2025, Alvotech and Advanz Pharma announced that the European Commission has granted marketing authorisations in the European Economic Area for Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab).  The approval covers both pre-filled syringe and autoinjector dosage forms (50 mg/0.5 mL and 100 mg/mL) of Gobivaz® for treating adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, and ulcerative colitis, and for treating juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate.

Gobivaz® is being commercialised by Advanz in the UK and Europe under a May 2023 licence and supply agreement with Alvotech, which is responsible for development and commercial supply of the product.

AVT05 was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan, where it is being commercialised by Fuji Pharma.  Also in September 2025, Gobivaz® received a positive opinion from the European Medicine Agency’s CHMP, after Alvotech/Advanz’s European MAA for that product was the first golimumab biosimilar MAA to be accepted anywhere in the world in November 2024.  Gobivaz® was approved in the UK in November 2025.

In the US, Alvotech/Teva’s Biologics License Application (BLA) for AVT05 was accepted by the FDA in January 2025.  The FDA issued a Complete Response Letter in relation to the BLA in early November 2025, with Alvotech working to resolve “certain deficiencies” identified following a manufacturing facility inspection.

A golimumab biosimilar, BAT2506, is also being developed by Bio-Thera, with an MAA for the product accepted in Europe in February 2025 (where it is being commercialised by STADA under a May 2024 agreement), and a BLA accepted for FDA review in July 2025 (with Accord responsible for US commercialisation).  Bio-Thera has entered into commercialisation agreements for BAT2506 with SteinCares for Latin America (March 2024) and Dr Reddy’s for South East Asia (March 2025).

On 20 November 2025, Accord BioPharma announced that it has received FDA approval for Osvyrti® and Jubereq®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications.  Accord plans to launch the denosumab biosimilars in the US in 2026.

In November 2024, Amgen commenced BPCIA proceedings against Accord/Intas, alleging infringement of 34 of Amgen’s US patents relating to denosumab and methods of its manufacture.  The litigation followed Accord/Intas’ submission of its abbreviated BLAs for its denosumab biosimilars.  The US litigation with Amgen settled in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025 (subject to regulatory approval).

There are a number of denosumab biosimilars approved and launched in the US: Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), and Richter/Hikma’s Enoby™and Xtrenbo™ (approved September 2025, not yet launched).

On 19 November 2025, Xbrane provided an update on the resubmission of its ranibizumab biosimilar BLA to the FDA following a Complete Response Letter (CRL) received in October 2025.  Xbrane expects to be able to resubmit its BLA in March 2026 following completion of corrective action to be taken at the production site of Xbrane’s relevant contract manufacturer.

According to Xbrane, following resubmissions of the BLA for its biosimilar to Genentech’s Lucentis®, an FDA 6-month review process is likely, resulting in an expected Biosimilar User Fee Amendment (BsUFA) date in September 2026.

The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with US biosimilars specialist Valorum Biologics, who will be responsible for commercialisation in the US, likely under the Lucamzi™ brand.

There are currently two ranibizumab biosimilars approved in the US.  The first approved was Samsung Bioepis’ Byooviz® (September 2021), followed by Formycon/Sandoz’s Cimerli® (August 2022).

On 19 November 2025, MSD announced that that the European Commission has approved its subcutaneous (SC) formulation of Keytruda®, to be marketed in the EU as Keytruda SC™ (pembrolizumab and berahyaluronidase alfa-pmph).  The marketing authorisation covers all 33 previously approved adult indications for Keytruda® (pembrolizumab) in Europe and follows a positive recommendation from the EMA’s CHMP in September 2025.

The subcutaneous formulation was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications.

MSD was sued by Halozyme in the US on 24 April 2025 in relation to SC pembrolizumab, with Halozyme alleging that it infringes 15 patents owned by Halozyme in relation to MDASE subcutaneous delivery platform.  The lawsuit followed reports in March 2025 that Halozyme had offered MSD an opportunity to licence its MDASE patents.  At the time, a spokesperson from MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD has filed petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of 14 of Halozyme’s US patents.  The petitions were filed between November 2024 and June 2025 and all 14 have been instituted.  The patents at issue are: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758, US 12060590, US 12049652, US 12104185, US 12037618, US 12091692, US 12077791, US 12195773 and US 12264345.

On 19 November 2025, Regeneron announced that the FDA has approved Eylea HD® (aflibercept, 8mg for injection) for macular oedema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period.  A 4-weekly dosing option has also been approved for patients who may benefit from resuming this dosing schedule across approved indications (nAMD, DME, DR and RVO).

Regeneron’s pre-filled syringe (PFS) supplementary BLA for Eylea HD® is still on hold while Regeneron seeks to resolve inspection findings at Catalent reported in an October 2025 Complete Response Letter from the FDA.  Catalent (part of Novo Nordisk) is the manufacturer filler included in Regeneron’s sBLA.  Regeneron plans to submit to the FDA an application to include an alternate PFS manufacturing filler for its Eylea HD® BLA by January 2026.

Regeneron’s Eylea HD® was approved in the US in a vial form for nAMD, DME and DR in August 2023.  Regeneron has submitted an application to include an additional vial filler in its BLA, with an FDA decision regarding this new vial filler expected by late December 2025.

Eylea® 8mg (as the product is known in other jurisdictions) is approved for nAMD and DME (as intravitreal injection) including in the EU (January 2024), Japan (January 2024), UK (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 treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).

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

On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be considered for reimbursement:

• Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP);
• Celltrion’s Yuflyma® (adalimumab) in 20mg/0.2ml PFS;
• Celltrion’s Omlyclo® (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP; and
• Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS.

Amgen received TGA approval for its high-concentration Amgevita® formulations (referencing AbbVie’s Humira® (adalimumab)) in September 2025.  In September 2024, Celltrion’s Yuflyma® was TGA approved in 20mg/0.2ml PFS.  Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (June 2023) forms and was PBS-listed in March 2023 (40mg/0.4ml).

In addition to Celltrion’s Yuflyma® and Amgen’s Amgevita®, there are a number of other high-concentration adalimumab biosimilars approved in Australia, including Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).

In September 2025, Celltrion announced the Australian launch of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in PFS presentations in November 2024 and PBS-listed on 1 August 2025.  The PFP formulations which will be considered by PBAC in March 2026 were approved in August 2025.

Sandoz’s Ardelya®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), will be considered by PBAC at its March 2026 meeting, although it has not yet received marketing approval in Australia.  While Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing.  As a result, 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 18 November 2025, Celltrion announced that it has received European Commission approval for a new 300 mg (2 mL) prefilled syringe form of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  According to Celltrion, the additional strength of Omlyclo® “can significantly decrease the frequency of injections and reduce injection burden and discomfort without compromising efficacy and safety”.

Omlyclo® is the first and only omalizumab biosimilar to be approved in the EU, with Celltrion’s 75 mg/0.5 mL and 150 mg/1 mL PFS formulations receiving EU market authorisation in May 2024.

Celltrion commenced its European rollout of Omlyco® with the launch of the product in Norway in September 2025.  Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).

Omalizumab biosimilars are also under development by Alvotech/Kashiv, Aurobindo, Teva and Glenmark.  In October 2025, Alvotech announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for its omalizumab biosimilar, AVT23.