Similar or the Same? Why Biosimilars are not the Solution

Advancements in the field of biotechnology have accelerated the development of drugs that are manufactured from cultures of living cells, commonly referred to as “biologics.” Due to the complexity of the production process, generic biologics are unlikely to be chemically identical to the reference p...

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Veröffentlicht in:	The Journal of law, medicine & ethics medicine & ethics, 2018-09, Vol.46 (3), p.776-790
Hauptverfasser:	Diependaele, Lisa, Cockbain, Julian, Sterckx, Sigrid
Format:	Artikel
Sprache:	eng
Schlagworte:	Biological products Biosimilar Pharmaceuticals Biotechnology Cell Line Clinical trials Clinical Trials as Topic Competition Disclosure Drug Approval Drug Industry Drugs, Generic Economic Competition FDA approval Generic drugs Health technology assessment Humans Labor process Manufacturers Market entry Medical research Ownership - legislation & jurisprudence Patents as Topic Pharmaceutical industry Production United States United States Food and Drug Administration
Online-Zugang:	Volltext
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