On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman disease (CD), and cytokine release syndrome (CRS).

This marks the first tocilizumab biosimilar approved in Japan, with Celltrion planning to launch “quickly” to secure “first mover advantage”.

In May 2025, Avtozma® became the first approved tocilizumab biosimilar in Australia.  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® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

On 21 September 2025, Medical Dialogues reported that Biocon has received recommendations from India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to import and market its biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in India for multiple ophthalmic indications (in 40mg/ml vial form for injection).  Biocon is required to submit a Phase IV (post-marketing) clinical trial protocol to the CDSCO within 3 months of the grant of marketing authorisation.

Biocon also announced on 18 September 2025 that Yesafili® (aflibercept), in vial and prefilled syringe presentations, is now publicly funded on the Ontario Drug Benefit Formulary/Comparative Drug Index for the advanced treatment of patients with retinal diseases.

Yesafili® was reported to be the first aflibercept biosimilar approved in Canada in June 2025 and was launched in July 2025 under a March 2024 settlement between Biocon and Regeneron/Bayer.

Biocon’s Yesafili® was approved in Europe in September 2023 but is not yet on the market.  In April 2025, Biocon and Regeneron settled US BPCIA litigation regarding aflibercept, paving the way for a US launch of Yesafili® in the second half of 2026, or earlier under certain undisclosed circumstances.

On 19 September 2025, MSD announced that Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph; MK-3475A) has been approved by the FDA for subcutaneous use in adults across 38 indications, covering most solid tumour indications for Keytruda® (pembrolizumab).  MSD is planning a late September 2025 US launch for Keytruda Qlex™.

According to Business Korea, if Keytruda Qlex™ successfully penetrates the market, Alteogen, the developer of hyaluronidase technology used with the subcutaneous formulation, is expected to generate annual royalty income exceeding 1 trillion won.

The FDA had accepted MSD’s BLA for SC pembrolizumab in March 2025, with a target action date of 23 September 2025.

The good news for MSD comes a day after the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a change to the marketing authorisation for MSD’s Keytruda®, adopting a new pharmaceutical form, solution for injection, associated with two new strengths (790 mg and 305 mg), together with subcutaneous use as a new route of administration.

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 14 petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of US patents owned by Halozyme, a number of which are asserted in the litigation.  The petitions were filed between November 2024 and June 2025.  Petitions in relation to 5 patents have been instituted (US 11952600 (2 June 2025), US 12018298 (11 June 2025), US 12152262 (16 June 2025), US 12123035 (11 July 2025), US 12110520 (8 September 2025)), while others are pending.

On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway.  The announcement comes only 9 days after Celltrion said that it was set to “launch in Europe as a ‘first mover’ within the year”.

On the same date, Celltrion also announced results from its global Phase 3 clinical trial of Omlyclo®, involving 619 patients with chronic spontaneous urticaria.  Starting from week 12, patients who received Omlyclo® were continued on the same treatment and patients who initially received 300mg of the reference product were re-randomised in a 1:1 ratio to either switch to Omlyclo® or to continue receiving the reference product.  The results demonstrated comparable efficacy and safety to the reference product.

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).  The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.

Aurobindo, Teva, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development.

On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market.  Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

On 19 September 2025, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare for 3 biosimilars:

• Golimumab: AVT05 (GOLIMUMAB BS 50 mg PFS for subcutaneous injection), biosimilar to Janssen’s Simponi®;
• Denosumab: AVT03 (DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection), biosimilar to Daiichi Sankyo’s Ranmark®, which is marketed in other countries as Amgen’s Xgeva®; and
• Aflibercept AVT06 (AFLIBERCEPT BS 40 mg/mL solution in PFS for IV injection and 40 mg/mL vial kit for IV injection), biosimilar to Regeneron/Bayer’s Eylea®.

Alvotech considers that the Japanese approval of AVT05 is the first golimumab biosimilar approval in any major market.  Alvotech/Fuji’s AVT04, biosimilar to J&J’s Stelara®, was the first ustekinumab biosimilar approved in Japan in September 2023.

Alvotech and Fuji Pharma first announced they had entered into a commercialisation agreement for Japan in 2018, with the agreement expanded in February 2022 and January 2023.  The agreement covers the four approved biosimilars, plus two unnamed biosimilar candidates currently under development.

In January 2025, Celltrion announced plans to launch its denosumab (CT-P41) and aflibercept (CT-P42) biosimilars in Japan during 2025, together with ustekinumab (CT-P43), omalizumab (CT-P39) and tocilizumab (CT-P47) biosimilars.

On 19 September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its September meeting, adopting positive opinions for the following nine biosimilars:

• Golimumab: Alvotech/Advanz Pharma’s Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab). In November 2024, Alvotech/Advanz Pharma’s European MAA for AVT05 was the first golimumab biosimilar MAA to be accepted anywhere in the world;
• Denosumab: STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, and Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) and Intas’ Denosumab Intas, biosimilar to Amgen’s Prolia® (denosumab);
• Ustekinumab: Bio-Thera/STADA’s Usgena™ (BAT2506), biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Bio-Thera and STADA entered an exclusive commercialisation agreement in relation to BAT2506 in May 2024 under which Bio-Thera has responsibility for development and manufacturing the biosimilar while STADA has exclusive commercialisation rights in the EU, UK, Switzerland and certain other countries.

There are currently 8 sponsors with denosumab biosimilars approved in Europe although none have launched to date: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025) and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025).  Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025.

There are no golimumab biosimilars approved in the EU, so Alvotech is likely to have the first EU approved biosimilar golimumab.  Following acceptance of Alvotech/Advanz’s MAA for AVT05 in November 2024, Bio-Thera/STADA’s MAA for BAT2506 was accepted by the EMA in February 2025.

There are a number of ustekinumab biosimilars now marketed in EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024 and Celltrion’s Steqeyma® launched in November 2024.  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 19 September 2025, Aurobindo Pharma subsidiary, CuraTeQ Biologics, announced positive results from its Phase 3 trial of BP16, biosimilar to Amgen’s Prolia® (denosumab).

The study, which was conducted across 40 sites in five European countries on 446 postmenopausal women, evaluated the biosimilar’s efficacy in improving bone mineral density (BMD) and reducing fracture risk.  The trial met all clinical endpoints, showing no clinically meaningful differences between the biosimilar and the reference product.

According to the announcement, CuraTeQ plans to begin regulatory submissions for BP16 in the EU, US, and other key regions from January 2026.

In April 2025, CuraTeQ reported successful Phase I results for BP16, which included 204 subjects from Australia and New Zealand, demonstrating comparable safety, pharmacodynamics and immunogenicity profiles to both the European and US versions of Prolia®.

On 19 September 2025, Shanghai Henlius and Organon announced that the European Commission has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Bildyos® and Bilprevda® in July 2025, following the acceptance of the marketing authorisation application by the European Medicines Agency in May 2024.

Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 (denosumab) for all countries except China, Hong Kong, Macau and Taiwan.

In June 2025, Amgen sued Henlius and Organon in the US in relation to their denosumab biosimilars, alleging infringement of 26 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.  Amgen also has pending BPCIA litigation against Hikma/Gedeon Richter and Biocon in relation to denosumab.  On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen was concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.

There are now 8 sponsors with denosumab biosimilars approved in the EU, although none have been launched to date, with previous approvals for: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025) and Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025).

On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications.

This makes Celltrion’s Stoboclo® and Osenvelt® the second pair of denosumab biosimilars approved in Canada, following Sandoz’s Wyost® (approved February 2024) and Jubbonti® (approved March 2024), which were launched in August 2024.

Celltrion’s denosumab biosimilars have been approved in various regions, including: Korea (approved November 2024, launched March 2025), Europe (approved February 2025, not yet launched), the US (approved March 2025, launched July 2025) and Australia (approved April 2025, not yet launched).

In May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation settled in January 2025, supporting the US launch of Celltrion’s denosumab biosimilars in July 2025.

On 18 September 2025, Samsung Bioepis’ Opuviz®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), was approved by Australia’s Therapeutic Goods Administration (TGA) in 2 presentations:

• OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial (456527)
• OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial with needle (456528)

The PI for Opuviz® is not yet available.

With this approval, Samsung Bioepis becomes the third sponsor with an approved aflibercept biosimilar in Australia.  Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV), which was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025.  Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme with listing anticipated on 1 December 2025.

Aflibercept is currently the subject of patent infringement proceedings in Australia.  On 8 September 2025, the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer an interlocutory injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®.  Regeneron/Bayer filed an application for leave to appeal that decision on 17 September 2025.  Regeneron/Bayer are separately seeking preliminary discovery from Sandoz in relation to a second Regeneron aflibercept patent, AU2020397865, which is scheduled for hearing on 6 November 2025.

Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia, filed revocation proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter currently scheduled for 8 October 2025.