mAbs
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As we begin a new year, the Editorial Board, Associate and Assistant Editors and Editor-in-Chief of mAbs would like to thank the reviewers who contributed their insights and advice, as well as suggestions for improvement of manuscripts submitted for publication in mAbs volume 5, issues 1-6 (2013). The peer-review process involved the investment of substantial time and effort by the experts listed below, and we sincerely appreciate their valuable input on the selection of relevant, high-quality articles for mAbs readers.
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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.