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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