Biogen and Bio-Thera Solutions to develop Actemra biosimilar

Biogen and Bio-Thera Solutions have entered into a commercialisation and license agreement to develop, manufacture and commercialise 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.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.

Dr Shengfeng Li, CEO of Bio-Thera Solutions, said: “This agreement allows Bio-Thera Solutions and Biogen to bring a potentially new biosimilar option to patients.”

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.

The transaction is expected to close in the second quarter of 2021.

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