Biosimilar Guidances: Broader Populations Permitted; More Immunogenicity Requested
New draft Q&A and three final guidances from FDA offer pros and cons for sponsors of biosimilar applications.
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With two new guidance documents, agency is trying to bring order to the potentially chaotic regulatory process that insulins and other currently approved protein products will face in March 2020; FDA also issues two more Q&A guidance documents on scientific and regulatory considerations for biosimilars.
Biosimilars will have same pharmacovigilance expectations as innovator biologics despite lack of clinical data for some extrapolated indications.
Even as applications themselves remain low burden, intense policy efforts put pressure on user fees.