首款生物类似药抗体在欧洲获批：生物制药行业的重要里程碑。
Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry.
机构信息
Centre d'Immunologie Pierre Fabre; Saint-Julien-en-Genevois, France.
出版信息
MAbs. 2013 Sep-Oct;5(5):621-3. doi: 10.4161/mabs.25864. Epub 2013 Jul 24.
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.
摘要
在欧洲药品管理局（EMA）和生物制药行业的一个决定性时刻，2013 年 6 月 27 日，EMA 的人用医药产品委员会通过了两项生物类似药英夫利昔单抗产品（Celltrion 的 Remsima®和 Hospira 的 Inflectra®）的积极意见，并建议批准在欧盟（EU）上市。欧洲委员会对申请的决定通常在提供意见后 67 天内作出；因此，预计在 2013 年 9 月初作出决定。如果获得批准，这些产品将成为首个在高度监管市场提供给患者的生物类似抗体，尽管由于欧盟中参考产品（Remicade®）专利的延长，推出可能会延迟。
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