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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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Osmane, Malik
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hamburg : Diplomica Verlag, 2014.
Temas:
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
Acceso en línea:Texto completo
Descripción
Sumario: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, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, cu.
Descripción Física:1 online resource (283 pages)
ISBN:9783954896875
3954896877

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