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    EU official says ICH Q6B is outdated and needs revision

    The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric approach and to include the science and risk-based concepts embodied in other ICH guidelines, according to a regulator from the EU.   Mats Welin, a senior expert for vaccines and monoclonal antibodies (MAbs) for the Swedish Medical Products Agency, made this assertion at the 30 November webi...
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    How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006 (Part 2)

    This two-part series provides insights into the new paradigm of biosimilar medicines based on approval and medical experience postapproval. It proposes a framework for the understanding, development and acceptance of a new generation of biologic medicines, biosimilars, in the US and worldwide. 1-3 Currently, the knowledge gathered by regulators and industry permits a degree of confidence in biosimilars authorized in the EU after nearly six years of pharmacovigilance, pr...
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    How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006

    This is the first of a two-part series on the pre- and postapproval clinical safety of known EU-approved biosimilar therapeutic protein medicinal products. It compares and contrasts EU experience with the long-awaited, overarching FDA biosimilars guidances. It also anticipates the safety of as-yet-unapproved potential biosimilars, including the recombinant mAbs, insulins, heparins and interferons. Biosimilar medicinal development strategy, perception of general risk, int...