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Under the 351(k) pathway, biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinicalpharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. of all NME approvals this year.
Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinicalpharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.
The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.
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