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Bio-Thera and Intas Partner to Commercialise Golimumab Biosimilar in US

Feb 10, 2025

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.