Biosimilars: opinion of an expert panel in the Middle East

ABSTRACT Background: Several biotechnology-derived drugs are reaching the end of their patent lives. As a result, so-called biosimilar products are in development, and a few have already gained approval in Europe and other countries such as the USA. Biosimilars, unlike generic versions of convention...

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Veröffentlicht in:	Current medical research and opinion 2008-10, Vol.24 (10), p.2897-2903
Hauptverfasser:	Bohlega, S., Al-Shammri, S., Sharoqi, I. Al, Dahdaleh, M., Gebeily, S., Inshasi, J., Khalifa, A., Pakdaman, H., Szólics, M., Yamout, B.
Format:	Artikel
Sprache:	eng
Schlagworte:	Biomimetic Materials - adverse effects Biomimetic Materials - pharmacokinetics Biomimetic Materials - pharmacology Biomimetics - methods Biomimetics - standards Biomimetics - trends Biosimilars Biotechnology-derived Guidelines Guidelines as Topic Humans Immunogenicity Interchangeability Investigational New Drug Application - legislation & jurisprudence Investigational New Drug Application - methods Investigational New Drug Application - organization & administration Middle East Registration Substitution
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