Biogen’s Tofidence (tocilizumab), a biosimilar referencing Roche’s RoActemra, has been approved by the European Commission (EC) to treat certain forms of arthritis and COVID-19.
The intravenously administered monoclonal antibody, developed by Bio-Thera, has been approved to treat moderate-to-severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
A biosimilar 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 EC’s decision on Tofidence follows a recent recommendation from the European Medicines Agency’s (EMA) human medicines committee and 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 approval “offers European patients with several inflammatory and immune-mediated inflammatory diseases access to an additional affordable biologic treatment option”.
Tofidence adds to the existing portfolio of three anti-TNF biosimilars commercialised by Biogen in Europe, including Benepali (etanercept), Imraldi (adalimumab) and Flixabi (infliximab).
“By adding Tofidence to our growing biosimilars portfolio, we can provide greater choice to physicians and patients while offering the potential for significant cost-savings across healthcare systems in Europe,” Henshaw said.
Biogen and Bio-Thera signed a global commercialisation agreement for Tofidence in 2021, which gave Biogen exclusive regulatory, manufacturing and commercial rights to the biosimilar in all countries excluding China, including Hong Kong and Macau, as well as Taiwan.
The therapy was approved by the US Food and Drug Administration in September to treat the same arthritis patient populations.
The latest approval comes less than two weeks after Celltrion shared positive phase 3 results for its own investigational RoActemra biosimilar in patients with moderate-to-severe rheumatoid arthritis.
Data from the phase 3 comparative clinical trial demonstrated that the candidate, CT-P47, has equivalent efficacy and a comparable safety and immunogenicity profile to the reference product. Regulatory applications for CT-P47 have already been filed with the US Food and Drug Administration and the EMA.