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MAbs. 2013 Sep-Oct;5(5):621-3. doi: 10.4161/mabs.25864. Epub 2013 Jul 24.

Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry.

Author information

1
Centre d'Immunologie Pierre Fabre; Saint-Julien-en-Genevois, France.

Abstract

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.

KEYWORDS:

Fc-fusion protein; adalimumab; antibody; bevacizumab; biobetters; biosimilars; cetuximab; etanercept; follow-on biologicals; infliximab; mass spectrometry; rituximab; trastuzumab

PMID:
23924791
PMCID:
PMC3851211
DOI:
10.4161/mabs.25864
[Indexed for MEDLINE]
Free PMC Article

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