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 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.

On 16 December 2024, Johnson & Johnson (J&J) announced that it submitted a supplemental Biologics Licence Application (sBLA) to the US FDA seeking the approval of Simponi® (golimumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis (UC).  This would add to the already approved indication of Simponi® for the treatment of adults with moderately to severely active UC. 

This news follows Alvotech and Advanz Pharma’s announcement in November 2024 that the European Medicines Agency (EMA) has accepted their marketing authorisation application (MAA) for their AVT05, biosimilar to Simponi® (golimumab), for treatment of several chronic inflammatory diseases.  This is thought to be the first golimumab biosimilar MAA to be filed and accepted anywhere in the world. 

On 13 November 2024, Alvotech announced its financial results for the first 9 months of 2024, reporting an increase in total revenues of US $300 million and an over four-fold increase in product revenue, year on year.

Product development highlights for the year to date include the EMA acceptance of marketing authorisation applications for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in October 2024, and AVT05 (golimumab), biosimilar to Janssen’s Simponi®, in November 2024.  Alvotech has commercialisation agreements for European markets with STADA and Dr Reddy’s in relation to AVT03 and with Advanz Pharma in relation to AVT05.

In October 2024, the US FDA also approved a new presentation of Alvotech and Teva’s Selarsdi®/AVT04 (ustekinumab-aekn), biosimilar to Janssen’s Stelara®, in a 130 mg/26mL single-dose vial for IV infusion and a label expansion to include treatment for Crohn’s disease and ulcerative colitis.  Alvotech expects a February 2025 US launch for Selarsdi®.

A further highlight is said to be Alvotech’s commencement in September 2024 of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.

Alvotech reports licence and other revenue for the first 9 months of 2024 totalling US$210.5 million, primarily attributable to R&D milestones for the approval of AVT04/Uzpruvo® (ustekinumab) in Europe in January 2024, the commencement of the AVT16 (vedolizumab) clinical trials, European MAA submissions for AVT03 (denosumab) and AVT06 (aflibercept), and confirmatory efficacy and safety trials completed for AVT03 (denosumab) and AVT05 (golimumab).  There was also achievement of a performance milestone for the product launch of AVT04 (ustekinumab) in Japan (as Ustekinumab BS (F)) and Europe (as Uzpruvo®), a sales target for AVT02 (adalimumab) in Europe and Canada, and a product launch of AVT02 (as Simlandi®) in the US.

On 4 November 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted their marketing authorisation application (MAA) for AVT05, biosimilar to Janssen’s Simponi® (golimumab), for treatment of several chronic inflammatory diseases.  This is thought to be the first golimumab biosimilar MAA to be filed and accepted anywhere in the world.  Alvotech/Advanz expect the approvals process to be completed in Q4 2025.

In April 2024, Alvotech was the first company to publicly announce positive topline results from a patient study evaluating a biosimilar candidate to Simponi® or Simponi Aria®.  In November 2023, Alvotech announced that its pharmacokinetic study for AVT05 met its primary endpoint.

Alvotech and Advanz Pharma entered into a master license and supply agreement in May 2023 to commercialise and supply AVT05 in Europe.  The agreement also included AVT16 (biosimilar to Takeda’s Entyvio® (vedolizumab) and three early stage, undisclosed biosimilar candidates.

On 28 May 2024, Bio-Thera and STADA announced they have entered an exclusive commercialisation agreement in relation to BAT2506, biosimilar to Janssen’s Simponi® (golimumab).   

Under the agreement, Bio-Thera has responsibility for developing and manufacturing BAT2506, while STADA has exclusive rights to commercialise the product in the EU, UK, Switzerland and certain other unnamed countries.  The agreement provides for an upfront payment to Bio-Thera of US$10M, plus milestone payments of up to US$147.5M, subject to fulfillment of certain conditions. 

This comes after last month’s announcement by Alvotech of positive topline results from a confirmatory clinical study of its golimumab biosimilar, AVT05. 

On 24 April 2024, Alvotech announced positive topline results from a confirmatory clinical study of AVT05 (golimumab), with the biosimilar demonstrating therapeutic equivalence to Janssen’s Simponi® and Simponi Aria® in patients with moderate to severe rheumatoid arthritis.

Alvotech is the first company to publicly announce positive topline results from a patient study evaluating a biosimilar candidate to Simponi® or Simponi Aria®.

These results follow Alvotech’s announcement in November 2023 that its pharmacokinetic study for AVT05 met its primary endpoint.

Alvotech announced that its pharmacokinetic study of AVT05, its Simponi®/Simponi Aria® (golimumab) biosimilar, met its primary endpoint.  The study assessed the pharmacokinetics, safety and tolerability of AVT05 compared to Simponi® in healthy adult subjects.

Alvotech announced the study in January 2023.  In May 2023, Alvotech announced a study in adult patients with moderate to severe rheumatoid arthritis.

Alvotech has provided updates on some of its biosimilar products in its report on its financial results for the first 3 months of 2023.

• As previously reported, Alvotech initiated a confirmatory patient study for AVT05, its proposed biosimilar to Simponi^® and Simponi Aria^® (golimumab).
• In March 2023, Alvotech provided Biosana Pharma a notice of termination for the licensing agreement between the two companies relating to AVT23, biosimilar to Xolair® (omalizumab). The deal was announced in February 2022.