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Biogen and Bio-Thera Solutions Announce Commercialization and License Agreement for Proposed Biosimilar Currently in Phase 3 With the Potential to Treat Moderate to Severe Rheumatoid Arthritis

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Biogen and Bio-Thera Solutions Announce Commercialization and License Agreement for Proposed Biosimilar Currently in Phase 3 With the Potential to Treat Moderate to Severe Rheumatoid Arthritis | Pharmtech Focus

Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. (688177.SH) today announced that they entered into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a Phase 3 clinical stage anti-interleukin-6 (IL-6) receptor monoclonal antibody that is a proposed biosimilar referencing ACTEMRA® (tocilizumab).

ACTEMRA®’s primary indication is for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome. In 2020 global sales of ACTEMRA® were 2.8 billion CHF. Biogen will gain exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan). Biogen will expand its global biosimilars footprint with the potential approval of BAT1806.

Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they offer cost savings. Biosimilars may lower healthcare system costs broadly, creating headroom for innovation and could enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.

“We are excited about this new transaction with Bio-Thera Solutions, a leading commercial-stage biopharmaceutical company in China, and how BAT1806 will augment our expanding portfolio of biosimilars assets,” said Chirfi Guindo, Head of Global Product Strategy and Commercialization at Biogen. “Biosimilars deliver sustainable value for patients, physicians, healthcare systems and society by expanding access to leading biologic therapies worldwide.”

“Bio-Thera Solutions is pleased to work with Biogen, one of the world’s first and leading global biotechnology companies, to commercialize BAT1806, our tocilizumab biosimilar program in all countries outside of China,” said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. “This agreement allows Bio-Thera Solutions and Biogen to bring a potentially new biosimilar option to patients.”

Under the terms of the agreement, Biogen will make an upfront payment of $30 million to Bio-Thera Solutions, contingent upon Bio-Thera Solutions’ Phase 3 for BAT1806 achieving satisfactory results. Should certain commercial milestones be achieved, Bio-Thera Solutions will be eligible to receive potential milestone payments. Biogen will also pay Bio-Thera Solutions tiered royalties.

Closing of the transaction is contingent upon completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S. The transaction is expected to close in the second quarter of 2021.

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