The BioCentury FoB article gets to the crux of the issue: Should a company develop an FoB, where the clinical program can be somewhat abbreviated and FDA approval in one indication may extend to related indications (#msg-58469454)… or should a company develop a regular biologic (via the BLA pathway), and thereby avoid disclosing IP to competitors?
If an applicant expects to achieve interchangeability, the FoB pathway is clearly preferable; however, if interchangeability is out of the question, the answer to the above question is not easily determined.
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