Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account : RIFT-LINES WITHIN EUROPEAN REGULATORY FRAMEWORK FOR BIOSIMILARS WHEN TAKING HETEROGENEITY AND VARIATION DURING LIFECYCLE OF THE REFERENCE BIOLOGIC AND THE BIOSIMILAR INTO ACCOUNT.

Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thu...

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Bibliographic Details

Call Number:	Libro Electrónico
Main Author:	Osmane, Malik
Format:	Electronic eBook
Language:	Inglés
Published:	Hamburg : Diplomica Verlag, 2014.
Subjects:	Biological products. Drugs > Generic substitution. Pharmaceutical biotechnology industry. Biological Factors Produits biologiques. Médicaments > Dénomination commune. Biotechnologie pharmaceutique > Industrie. Biological products Drugs > Generic substitution Pharmaceutical biotechnology industry
Online Access:	Texto completo