CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of TOFIDENCE™, a biosimilar to the reference product ROACTEMRA®. The positive opinion from CHMP is a crucial step towards the authorization of TOFIDENCE for use in the European Union.
TOFIDENCE, an interleukin-6 receptor antagonist, is indicated for the treatment of several conditions, including moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19 in certain adult patients. The recommendation for approval is based on a comprehensive package of analytical, non-clinical, and clinical data demonstrating the biosimilarity of TOFIDENCE to its reference product.
The CHMP's recommendation will now be referred to the European Commission, which has the authority to grant marketing authorization for the medication. If approved, TOFIDENCE will join Biogen's current portfolio of anti-TNF biosimilars in Europe, potentially providing a more cost-effective treatment option for patients with inflammatory and immune-mediated conditions.
Ian Henshaw, Global Head of Biosimilars at Biogen, remarked on the significance of the CHMP's endorsement, highlighting the company's commitment to expanding access to high-quality biologic medicines in Europe.
The clinical evidence supporting the CHMP's positive opinion included a Phase 1 study comparing the pharmacokinetics, safety, and immunogenicity of TOFIDENCE with the EU and US versions of tocilizumab in healthy volunteers. Additionally, a Phase 3 study demonstrated equivalent efficacy and comparable safety profiles between TOFIDENCE and tocilizumab in patients with rheumatoid arthritis.
Biogen's partnership with Bio-Thera, formed in April 2021, grants Biogen exclusive rights to commercialize TOFIDENCE in the European Union, with the exception of China (including Hong Kong, Macau, and Taiwan).
Founded in 1978, Biogen is a leader in biotechnology, focusing on developing treatments that significantly improve patients' lives. The company's approach involves taking calculated risks to advance therapies that offer superior outcomes.
InvestingPro Insights
As Biogen Inc. (NASDAQ:BIIB) awaits the European Commission's decision on TOFIDENCE, the company's financial health and stock performance provide context to its market position. Biogen, with a market capitalization of $29.48 billion, remains a significant player in the biotechnology industry. The company's commitment to innovation in biosimilars is also reflected in its financials, with a reported revenue of $9.66 billion over the last twelve months as of Q1 2024, despite a slight revenue decline of -4.37% in the same period.
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