All Data requirements articles
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PodcastsRegRapPod − In Conversation with TOPRA’s RegOps SPIN
BONUS EPISODE: In Conversation with TOPRA’s RegOps SPIN
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JournalRegulatory complexities and challenges of biosimilars
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.