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The BPCIA 351(k) Pathway: Two Tiers, One Critical Commercial Distinction The BPCIA created the 351(k) abbreviated biologics license application (aBLA) pathway, which allows a biosimilar applicant to rely on the FDA’s prior review of the reference product’s safety, purity, and potency data rather than independently generating that entire dataset
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If you evaluate a probiotic after two weeks, you are not measuring the product effectiveness
