Claudia Sailer

Claudia Sailer is Director, CMC Regulatory Affairs, Novartis.

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    Journal

    Regulatory complexities and challenges of biosimilars

    2022-06-15T10:09:00

    This continuing professional development (CPD) supplement focuses on the regulatory complexities and challenges associated with biosimilar products and their development. Although biosimilar products have been registered and approved for use in the EU for more than a decade, there is increasing speculation and excitement on the potential for biosimilars with increasingly complex structures, eg, multi-subunit, extensively post-translationally modified, and lipid-containing products.