Biogen has reached a license agreement with Bio-Thera Solutions to develop, manufacture and commercialise BAT1806, a proposed biosimilar to Roche’s Actemra (tocilizumab).

Bio-Thera is a commercial-stage biopharmaceutical company, focused on the research and development of novel therapeutics, along with biosimilars for existing biologics.

Under the terms of the agreement, Biogen will make an upfront payment of $30m to Bio-Thera, based on the success of Phase 3 clinical trials.

Bio-Thera is also eligible to receive additional payments based on achieving certain commercial milestones, along with tiered royalties.

The transaction is anticipated to close in the second quarter of 2021, subject to completion of the review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the US.

Bio-Thera Solutions CEO Shengfeng Li said: “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.

“This agreement allows Bio-Thera Solutions and Biogen to bring a potentially new biosimilar option to patients.”

Biosimilars are biologic products with similar in efficacy, safety and immunogenicity to the originally approved reference product, while providing the advantage of cost savings, said Biogen.

BAT1806 is an anti-interleukin-6 (IL-6) receptor monoclonal antibody, currently being studied under Phase 3 clinical trials.

Actemra was primarily indicated for moderate to severe rheumatoid arthritis in adults, along with juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome.

Biogen will secure exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan).

The company aims to expand its global biosimilars footprint with the potential regulatory approval of the BAT1806.

Biogen global product strategy and commercialisation head Chirfi Guindo said: “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.

“Biosimilars deliver sustainable value for patients, physicians, healthcare systems and society by expanding access to leading biologic therapies worldwide.”