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Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry
In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion’s Remsima® and Hospira’s Inflectra®), and recommended th...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Landes Bioscience
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3851211/ https://www.ncbi.nlm.nih.gov/pubmed/23924791 http://dx.doi.org/10.4161/mabs.25864 |
Sumario: | In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion’s Remsima® and Hospira’s Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission’s decision on an application is typically issued 67 d after an opinion is provided; thus, decisions are expected in early September 2013. If approved, the products will comprise the first biosimilar antibody made available to patients in a highly regulated market, although launch may be delayed due to an extension of the reference product’s (Remicade®) patent in the EU. |
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