Biogen edges out competition to win first FDA approval for Actemra biosimilar | BIIB Message Board Posts


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Msg  828 of 836  at  10/3/2023 4:56:18 PM  by

jerrykrause


Biogen edges out competition to win first FDA approval for Actemra biosimilar

Pharma & Healthcare Monitor Worldwide
 

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 Roches 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 companys financials.

Biogen has a biosimilar catalogue that generated $1.95bn in sales in Q2 2023, as per the companys financials. The portfolio includes another rheumatoid arthritis therapy, Benepali, a biosimilar for Amgens 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 Tofidences non-inferiority compared with Actemra.

 


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