Less restrictive requirements for studies to support the use of global comparator products that have been incorporated in the US Food and Drug Administration’s final guidance on biosimilar interchangeability have met with approval from local industry body the Association for Accessible Medicines.
FDA’s Interchangeability Improvements Impress Industry
Using comparator biologics not licensed in the US is foreseen in final FDA interchangeability guidance, shifting the agency’s previous stance on biosimilars.
