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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

Nachrichtenquelle: globenewswire
08.04.2021, 13:00  |  105   |   |   

  • Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA (tocilizumab)
  • Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability

CAMBRIDGE, Mass. and GUANGZHOU, China, April 08, 2021 (GLOBE NEWSWIRE) -- 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 ACTEMRA1 (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.2 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.”

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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 Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA (tocilizumab)Biosimilars have the potential to enable greater access to marketed biologic …

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