Bio-Thera focuses on therapeutics for cardiovascular, cancer and autoimmune conditions. Credit: sergey kolesnikov/Shutterstock.

Bio-Thera Solutions has signed an exclusive licence and commercialisation agreement with Intas Pharmaceuticals for the Simponi (golimumab) biosimilar, BAT2506 in the US.

Bio-Thera will develop, manufacture and supply BAT2506. It is set to obtain an upfront payment of $21m and could earn up to $143.5m in development and commercial milestones.

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Intas will handle commercialisation in the US market through its US speciality division, Accord BioPharma.

Accord BioPharma US president Chrys Kokino stated: “Our exclusive commercialisation agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our US growth strategy.

“We’re investing heavily in biosimilars through external partnerships plus our own clinical efforts because we believe in their vast potential to drive patient and provider-centric solutions. Bio-Thera’s global experience makes them an excellent partner.”

The human immunoglobulin G 1 (IgG1) monoclonal antibody golimumab is used to target a pro-inflammatory molecule, tumour necrosis factor alpha (TNF-α).

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The binding of the molecule to TNF-α can lead to a decrease in inflammatory markers.

Golimumab is approved for treating ulcerative colitis, psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis in the US and Europe.

Based in Guangzhou, China, Bio-Thera Solutions focuses on therapeutics for cardiovascular, cancer, autoimmune and eye conditions. It also focuses on biosimilars for existing branded biologics.

The company has advanced multiple candidates into late-stage development, with four approved products: Qletli and Betagrin in China, and Tofidence/BAT1806 and Avzivi/Pobevcy in the US, European Union and China.

In April 2021, Biogen and Bio-Thera entered an agreement to develop, manufacture and commercialise BAT1806, an anti-interleukin-6 (IL-6) receptor monoclonal antibody.