FDA: Draft Guidance for Manufacturing Changes of Biosimilars
The US Food and Drug Administration (FDA) released a draft guidance detailing how manufacturers should report postapproval manufacturing changes for licensed biosimilar and interchangeable products.
Presented in a question-and-answer format, the draft addresses "commonly asked questions" regarding postapproval manufacturing changes. The Q&A outlines three postapproval reporting categories for manufacturing changes: major changes requiring a prior approval supplement (PAS), moderate changes needing a changes being effected-30 days supplement (CBE-30), and minor changes that only require an annual report.
The guidance recommends using a "well-qualified, in-house reference material" for comparability studies to evaluate changes' effects on biosimilars or interchangeable biosimilars. It also addresses introducing these products into multiproduct manufacturing facilities, emphasizing the need for risk assessment and control measures to maintain quality, including identity testing.
The FDA advises consulting three guidances on reporting manufacturing changes: the 1997 guidance on changes to approved applications, the December 2021 guidance on CMC postapproval changes, and the June 2021 guidance on Chemistry, Manufacturing, and Controls changes. Applicants should also follow the International Council for Harmonization’s (ICH) Q5E guidance on biotech comparability when making manufacturing changes.
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