The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting of marketing authorization for an adalimumab biosimilar.
The adalimumab biosimilar, which will be called Yuflyma (CT-P17), has been developed by South Korea-based biotechnology company Celltrion Healthcare (Celltrion).
The drug is a biosimilar of AbbVie’s Humira (adalimumab), a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.
The positive opinion from EMA’s CHMP recommends that Yuflyma be used for the treatment of certain inflammatory and autoimmune disorders. The opinion is based on the phase I/III studies to evaluate pharmacokinetics (PK), efficacy and safety between CT-P17 and reference adalimumab. The clinical data, according to Celltrion, support the conclusion of biosimilarity of the proposed biosimilar and adalimumab to the reference product in terms of safety, efficacy, PK/pharmacodynamics (PD) and immunogenicity.
The CHMP positive opinion will now be considered by the European Commission (EC). Once approved the EC will grant a centralized marketing authorization for member countries of the European Union (EU). The data package included a randomised, double-blind phase III study in rheumatoid arthritis patients demonstrating similarity in terms of efficacy, PK and safety, including immunogenicity up to 24 weeks. Celltrion reported at the American College of Rheumatology Convergence 2020 conference that ‘CT P17 met the primary objective of demonstrating equivalent efficacy and its safety profile was comparable to that of reference adalimumab’ [1].
Celltrion expects the decision on the EC’s approval in the first quarter of 2021. Assuming it receives final EU approval, Yuflyma will be the sixth of Celltrion’s biosimilars to receive approval in the EU. There are already 11 other adalimumab biosimilars approved in Europe. The first adalimumab biosimilars, Cyltezo and Solymbic, were approved in March 2019 [2]. EMA is also reviewing another adalimumab biosimilar [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar advances for Celltrion Healthcare [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-advances-for-Celltrion-Healthcare
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar applications under review by EMA –January 2021 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-January-2021
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| LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
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