Biogen edges out competition to win first FDA approval for Actemra biosimilar
Biogen has entered the crowded arthritis market in the US following approval of its biosimilar Tofidence (tocilizumab-bavi) by the US Food and Drug Administration (FDA).
The agency approved the biosimilar for all the indications where the reference biologic – Roche’s Actemra – is approved. This includes moderate-to-severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
Actemra is a humanised monoclonal antibody directed against the interleukin-6 receptor. It is a high-grossing immunology drug for Roche and generated SFr1.29bn ($1.4bn) in sales in H1 2023, as per the company’s financials.
Biogen has a biosimilar catalogue that generated $1.95bn in sales in Q2 2023, as per the company’s financials. The portfolio includes another rheumatoid arthritis therapy, Benepali, a biosimilar for Amgen’s Enbrel (etanercept), which pulled in most of the Q2 revenue and $1.09bn in sales.
Tofidence was developed by Bio-Thera, with Biogen holding exclusive regulatory, manufacturing and commercial rights to the drug in all countries except China (including Hong Kong, Macau and Taiwan).
The FDA approval was based on a data package that included an analysis of the non-clinical and clinical results. The clinical data consisted of a Phase I study in healthy volunteers and a Phase III trial in patients with rheumatoid arthritis inadequately controlled by methotrexate, which showed Tofidence’s non-inferiority compared with Actemra.
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By GlobalData
It also has a boxed warning for the risk of developing serious infections, especially when used in conjunction with immunosuppressants such as methotrexate or corticosteroids.
Other companies that are developing Actemra biosimilars include Fresenius Kabi, which is researching a subcutaneous formulation of the biologic. GlobalData forecasts that Actemra biosimilars could generate $263.2m and $116.8m in sales, respectively, in the US and the five major European markets (France, Germany, Italy, Spain and the UK) by 2027.
GlobalData is the parent company of Pharmaceutical Technology.
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