On 2 November 2025, Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s Biologics Licence Application (BLA) for AVT05, biosimilar to J&J’s Simponi® (golimumab) in pre-filled syringe and autoinjector presentations.  The CRL follows a pre-licence inspection of Alvotech’s Reykjavik manufacturing facility in July 2025 which identified “certain deficiencies” to be resolved.  The CRL did not identify any other deficiencies with the BLA.

Alvotech’s Chairman and CEO, Robert Wessman, said that Alvotech is “disappointed in receiving the CRL” but expects “to resolve any outstanding issues and will continue to work with the FDA to bring this first to market biosimilar to patients in the US”.

AVT05 is being commercialised in the US by Teva pursuant to a strategic partnership entered into with Alvotech in August 2020.  Alvotech/Teva’s Biologics Licence Application (BLA) for AVT05 was accepted by the FDA in January 2025.

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.  It was also the subject of the first golimumab biosimilar MAA to be accepted anywhere in the world, when the European MAA for AVT05/Gobivaz® was accepted in November 2024.  Gobivaz® received a positive CHMP opinion in Europe in September 2025.

On 9 October 2025, Bio-Thera Solutions announced that it has entered an exclusive commercialisation and licence agreement for Canada with Intas Pharmaceuticals in relation to BAT2506, biosimilar to J&J’s Simponi® (golimumab).

This expands the existing partnership between the companies in relation to commercialisation of BAT2506 in the US, under a February 2025 agreement.  Under that agreement, Intas’ subsidiary, Accord BioPharma, is responsible for commercialising BAT2506 in the US, while Bio-Thera retains responsibility for development, manufacturing and supply.  Bio-Thera receives an upfront payment of US$21 million and further development and commercial milestone payments of up to US$143.5 million.  The financial arrangements in relation to the Canadian expansion of the partnership have not been published.

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

On 7 October 2025, Johnson & Johnson announced that the FDA has approved Simponi® (golimumab) for treating children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg.  The FDA approval follows J&J’s submission of the sBLA for this indication in December 2024.

Simponi® has previously been FDA approved for adults with moderately to severely active UC, moderate to severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.

The first golimumab biosimilar to be approved worldwide was Alvotech/Fuji Pharma’s AVT05, which received approval in Japan in September 2025.  Earlier in September 2025, Alvotech/Advanz’s Gobivaz® received a positive opinion from the European Medicine Agency’s CHMP, after the European MAA for that product was the first golimumab MAA to be accepted anywhere in the world (November 2024).  Alvotech/Teva’s Biologics Licence Application (BLA) for AVT05 was accepted by the FDA in January 2025, with approval expected in Q4/2025.

Bio-Thera/STADA’s MAA for the golimumab biosimilar BAT2506 was accepted by the EMA in February 2025, while Bio-Thera/Accord’s BLA for BAT2506 was accepted for FDA review in July 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 16 July 2025, Bio-Thera Solutions announced that the FDA has accepted for review its Biological Licence Application (BLA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab).  BAT2506 is being developed and manufactured by Bio-Thera and will be commercialised in the US by Intas Pharmaceuticals’ subsidiary, Accord Biopharma, under a February 2025 agreement.

The BAT2506 BLA is the second BLA for a golimumab biosimilar to be accepted by the FDA, following acceptance of Alvotech/Teva’s BLA for AVT05 in January 2025, approval of which is expected in Q4 2025.

Accord’s BLA for BAT2506 requests approval for all currently approved indications of Simponi®, including the following treatments for adults: moderately to severely active rheumatoid arthritis (RA) (with methotrexate), active psoriatic arthritis (alone or with methotrexate), active ankylosing spondylitis and moderately to severely active ulcerative colitis.

Bio-Thera has entered commercialisation agreements for BAT2506 in jurisdictions outside the US, including with SteinCares for Latin America (March 2024), STADA in Europe, the UK and selected other countries (May 2024), and Dr Reddy’s for South East Asia (March 2025).

In February 2025, Bio-Thera/STADA’s European marketing authorisation application (MAA) for BAT2506 was accepted by the European Medicines Agency (EMA).  In November 2024, Alvotech/Advanz Pharma’s European marketing authorisation application for AVT05 was the first golimumab biosimilar MAA to be accepted anywhere in the world.

On 26 March 2025, Bio-Thera Solutions and Dr Reddy’s announced that they have entered exclusive commercialisation and licence agreements for BAT2206 and BAT2506, biosimilars to J&J/Janssen’s Stelara® (ustekinumab) and Simponi® (golimumab), respectively.

Under the agreement, Bio-Thera will be responsible for developing, manufacturing and supplying BAT2206 and BAT2506 and Dr Reddy’s will commercialise the products in certain Southeast Asian countries, including Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam.  Dr Reddy’s will also receive the exclusive commercial rights to BAT2206 in Colombia.  The SE Asia deal follows agreements that Bio-Thera entered with Intas/Accord in February 2025 and STADA in May 2024 for the commercialisation of golimumab (BAT2506) in the US and Europe, respectively.

In October 2024, Bio-Thera and Gedeon Richter entered into an exclusive commercialisation and licence agreement for BAT2206 (ustekinumab), under which Richter has exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries.  Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA, and its BLA was accepted by the FDA, in July 2024.  A marketing authorisation application is also currently under review by China’s National Medicinal Product Administration.

On 10 February 2025, Bio-Thera Solutions announced that it has entered an exclusive US commercialisation and licence agreement with Intas Pharmaceuticals for BAT2506 (golimumab), biosimilar to J&J’s Simponi® and Simponi Aria®.

Under the agreement, Intas Pharmaceuticals’ subsidiary Accord BioPharma will be responsible for commercialising the product in the US, while Bio-Thera will retain responsibility for development, manufacturing and supply of BAT2506.  Bio-Thera will receive an upfront payment of US$21 million and further development and commercial milestone payments of up to US$143.5 million.

In May 2024, Bio-Thera entered an exclusive agreement with STADA for the commercialisation of BAT2506 in Europe.  In June 2021, it announced the commencement of a Phase 3 trial of BAT2506 in psoriatic arthritis, which was completed in 2023.

In November 2024, Alvotech/Advanz Pharma’s European marketing authorisation application for AVT05 was the first golimumab biosimilar MAA to be filed and accepted anywhere in the world.

On 7 February 2025, Bio-Thera announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab).

BAT2506 is being developed and manufactured by Bio-Thera and will be commercialised by STADA in Europe, the UK, Switzerland and certain other countries under a May 2024 exclusive commercialisation agreement.

In November 2024, Alvotech/Advanz Pharma’s European MAA for AVT05 was the first golimumab biosimilar MAA to be filed and accepted anywhere in the world.

On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® and Simponi Aria® (golimumab), which are indicated for a variety of chronic inflammatory diseases.  This is the first BLA filing acceptance for biosimilar golimumab in the US.

Alvotech/Advanz Pharma’s marketing authorisation application (MAA) for AVT05 was accepted by the European Medicines Agency in November 2024.  This was the first golimumab biosimilar MAA to be filed and accepted anywhere in the world.

Alvotech expects the approvals process in both the EU and the US to be completed in Q4 2025.

AVT05 is being commercialised in the US by Teva pursuant to a strategic partnership entered into with Alvotech in August 2020.  In May 2023, Alvotech and Advanz Pharma entered into a master licence and supply agreement to commercialise and supply AVT05 in Europe.