Biogen has announced that Tofidence (tocilizumab-bavi), a biosimilar referencing Roche’s RoActemra, has been recommended by the European Medicines Agency’s human medicines committee to treat certain forms of arthritis and COVID-19.
The intravenously administered monoclonal antibody, developed by Bio-Thera, has been recommended to treat moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
A biosimilar, according to the EMA, is a biological medicine that is highly similar to one already approved in the EU. This means that patients can expect the same safety and effectiveness from the biosimilar, which is usually less costly for healthcare systems, as they would from the reference product.
The Committee for Medicinal Products for Human Use’s (CHMP) decision on Tofidence was supported by an analytical, non-clinical and clinical data package demonstrating the biosimilar’s similarity to RoActemra.
Ian Henshaw, global head of biosimilars at Biogen, said: “The positive CHMP recommendation for Tofidence marks another positive step toward helping more people with inflammatory and immune-mediated conditions gain access to leading therapies.”
The recommendation will now be referred to the European Commission, which will decide whether to grant marketing authorisation for Tofidence. If approved, the drug will add to the existing portfolio of three anti-TNF biosimilars commercialised by Biogen in Europe, including Benepali (etanercept), Imraldi (adalimumab) and Flixabi (infliximab).
Tofidence was approved by the US Food and Drug Administration in September to treat moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
Henshaw said at the time of the announcement: “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.”
Biogen and Bio-Thera signed a global commercialisation agreement for Tofidence in 2021. As part of the deal, Biogen has exclusive regulatory, manufacturing and commercial rights to the biosimilar in all countries excluding China, including Hong Kong and Macau, as well as Taiwan.