Biosimilars and Safety Issues

E. Yiannakopoulou
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Abstract

Nowadays there is ongoing interest in the development of biosimilars, as biosimilars are anticipated to lead to price competition and to lower healthcare costs The first biosimilar, Omnitrope®, a biosimilar agent of the Recombinant Human Growth Hormone [rhGH]; was approved in Europe by the European Medicines Agency in 2006. Since then, 20 biosimilars have been approved in Europe including hematopoietic growth factors, insulin, monoclonal antibodies.
生物仿制药和安全问题
目前,人们对生物仿制药的开发一直很感兴趣,因为生物仿制药有望导致价格竞争和降低医疗成本。第一种生物仿制药是Omnitrope®,一种重组人生长激素(rhGH)的生物仿制药;2006年在欧洲获得了欧洲药品管理局的批准。从那时起,20种生物仿制药已在欧洲获得批准,包括造血生长因子、胰岛素、单克隆抗体。
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