fb image 1094 captis executive search management consulting leadership board services

Biogen and Bio-Thera Solutions announce commercialisation and license agreement for BAT1806

fb image 1094 captis executive search management consulting leadership board services

Biogen and Bio-Thera Solutions have entered into a commercialisation and license agreement for the development, manufacturing and commercialisation of BAT1806.

Biogen and Bio-Thera Solutions have entered into a commercialisation and license agreement for the development, manufacturing and commercialisation of BAT1806.

The terms of the agreement stipulate that Biogen makes an upfront payment of $30m to Bio-Thera Solutions, depending upon satisfactory results achieved from Bio-Thera Solutions’ Phase 3 for BAT1806.

With the achievement of specific commercial milestones, Bio-Thera Solutions could receive further milestone payments. Bio-Thera Solutions is also eligible for tiered royalties from Biogen.

BAT1806 is a Phase 3 clinical stage anti-interleukin-6 (IL-6) receptor monoclonal antibody that is a proposed biosimilar referencing ACTEMRA (tocilizumab).

ACTEMRA is used to treat moderate to severe rheumatoid arthritis in adults, along with juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome.

ACTEMRA’s last year global sales touched $3.02bn (2.8bn CHF).

With the potential approval of BAT1806, Biogen plans to expand its global biosimilars footprint. It will also gain exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries except China (and its special administrative regions Hong Kong, Macau and Taiwan).

Biosimilars are biologic products demonstrating similar efficacy, safety and immunogenicity to the originator’s approved reference product, and have the advantage of being cost effective.

Overall, biosimilars may cut costs in the healthcare system, giving scope for innovation and enabling governments to prioritise savings towards providing more access to transformative therapies.

Biogen Global Product Strategy and Commercialization 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.”

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 commercialise 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.”

Closing of the transaction depends upon review completion under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the US.

Time period for closing of the transaction is expected to be in Q2 2021.

This is not a CAPTIS article. Originally, it was published here.