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 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.
Centre d'Immunologie Pierre Fabre; Saint-Julien-en-Genevois, France.
Alain
A
Beck
Janice M
JM
Reichert
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D017277:Drug Approval; D004345:Drug Industry / Q000639:trends; D005060:Europe; D005062:European Union; D006801:Humans; D000069285:Infliximab
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; D000069285:Infliximab
Fc-fusion protein; adalimumab; antibody; bevacizumab; biobetters; biosimilars; cetuximab; etanercept; follow-on biologicals; infliximab; mass spectrometry; rituximab; trastuzumab