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Biogen scores US nod for Actemra biosimilar Tofidence
临床3期上市批准生物类似药临床结果专利侵权
Biogen announced Friday that it obtained FDA approval for Tofidence (tocilizumab-bavi), making it the first biosimilar monoclonal antibody referencing Roche's IL-6 receptor antagonistIL-6 receptor antagonist Actemra cleared in the US. "The approval…marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies," stated Ian Henshaw, global head of biosimilars at Biogen.
Tofidence is approved to treat moderately-to-severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. Biogen said the US nod was based on a data package that included an extensive analytical characterisation supporting biosimilarity with the reference product. In addition, an early-stage trial compared Tofidence with both the US and EU reference tocilizumab in healthy volunteers, while a Phase III study compared it with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles in rheumatoid arthritis patients inadequately controlled by methotrexate.
"The totality of evidence demonstrated Tofidence is a biosimilar of the reference biologic," the company said, adding it is currently evaluating a potential launch timeline in the US. As part of a 2021 agreement with Bio-Thera, which developed Tofidence, Biogen will sell the biosimilar in the US, and also has exclusive regulatory, manufacturing and commercial rights to the product in all countries except China.
Spending on therapies for autoimmune diseases has risen consistently by 10% to 25% per year over the past decade, the company said citing data from the Association for Accessible Medicines. "With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics," Henshaw remarked.
Roche had recently filed a lawsuit in US federal court claiming that Biogen's biosimilar, which is also known as BIIB800, infringes several patents. Last year, regulators in the EU, where tocilizumab is marketed as RoActemra, accepted to review Biogen's biosimilar application as well. Meanwhile, Fresenius Kabi's Tyenne (tocilizumab) a few weeks ago became the first biosimilar referencing RoActemra to be authorised in Europe.
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