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In Support of Global Comparator for Biosimilars Waiving bridging studies concerning local versus global reference products

by webmaster | Mar 17, 2025 | Policy & Regulation

I. Introduction The initial approval of a novel medicine in a country or region is usually supported by the same quality, non-clinical and pivotal clinical study datasets used for approval in other jurisdictions (notwithstanding additional clinical studies may be...

IGBA position on Streamlined Development

by webmaster | Mar 17, 2025 | Policy & Regulation, Uncategorized

Position: Today’s regulatory science supports the development of biosimilars based on analytical (physicochemical and functional) data and a clinical pharmacokinetic study (which includes safety and immunogenicity data) alone. Clinical comparative efficacy studies...
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