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Biogen and Bio-Thera enter a licencing agreement

Biogen and Bio-Thera Solutions have signed an agreement to develop, manufacture and commercialise the anti-interleukin-6 receptor monoclonal antibody BAT1806.BAT1806 is a proposed biosimilar referencing Actemra. It is mostly used for treating moderate to severe rheumatoid arthritis in adults and for juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome.

In the commercialisation and license agreement, Bio-Thera Solutions will receive a payment of $30m from Biogen on Phase III trial of BAT1806 achieving satisfactory results. Bio-Thera is capable of potential milestone payments on meeting some commercial milestones as well as tiered royalties.Biogen Global Product Strategy and Commercialisation head Chirfi Guindo is excited about this new transaction with Bio-Thera Solutions. is a commercial-stage biopharmaceutical company in China and how BAT1806 will augment our expanding portfolio of biosimilars assets. Biosimilars deliver sustainable value for patients, physicians, healthcare systems and society by expanding access to leading biologic therapies worldwide.

The company will have exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries except China. Bio-Thera Solutions CEO Dr Shengfeng Li said the company is pleased to work with Biogen, one of the world’s first and leading global biotechnology companies, to commercialise BAT1806, our tocilizumab biosimilar programme in all countries outside of China.

Closing of the transaction is contingent upon completion of review under antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the U.S. The transaction is expected to close in the second quarter of 2021.BAT1806 and Actemra both work by blocking a pro-inflammatory protein called IL-6. Since it hit the U.S. market in 2010, Actemra has been approved to treat about half a dozen diseases, including several kinds of arthritis. In 2020, the drug brought in sales of $3.1 billion for its developer, Roche.

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