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.