Biogen and Bio-Thera’s Phase 3 study for arthritis biosimilar meets primary endpoints

By Rachel Arthur

- Last updated on GMT


Related tags Biosimilars Monoclonal antibodies

A Phase 3 study of BAT1806, a proposed biosimilar referencing Actemra/RoActemra (tocilizumab), has shown equivalent efficacy and a comparable safety profile in patients with moderate-to-severe rheumatoid arthritis.

In April, Biogen and Bio-Thera Solutions entered into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, an anti-interleukin-6 (IL-6) receptor monoclonal antibody.

Biogen gains exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan), allowing the Cambridge, Massachusetts company to expand its global biosimilars footprint.

With the Phase 3 study achieving satisfactory results, Biogen will make an upfront payment of $30m to Guangzhou, China’s Bio-Thera.

Cost savings and healthcare sustainability

The primary indication for Roche / Genentech's Actemra 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 2.8bn CHF ($3.13bn). It is approved in 116 countries including the US, EU and China (In the US, it was launched in 2010 where it now has six approved indications).

The Biogen and Bio-Thera Phase 3 study used the American College of Rheumatology 20 percent response criteria (ARC20) as the primary endpoint, with the candidate demonstrating equivalence to the Actemra reference medicine in patients with moderate to severe rheumatoid arthritis inadequately controlled by methotrexate therapy.

“We are excited about these results and believe BAT1806 demonstrates equivalence in efficacy and pharmacokinetics as well as a comparable safety and immunogenicity profile to the reference product,”​ said Ian Henshaw, head of global biosimilars at Biogen.

“Biosimilars have the potential to generate cost savings, healthcare sustainability and, if approved, BAT1806 would enable us to bring an additional therapeutic option to patients.”

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