Biosimilars are highly similar to an already approved reference biologic, with no clinically meaningful differences in terms of safety, purity, or potency.
Composition:
While intended to be similar to the reference product, biosimilars may exhibit slight differences due to their complex nature and inherent variability in biological systems.
Regulation:
Regulated by the FDA under a distinct approval pathway established by the Biologics Control Act, biosimilars require a Biologics License Application (BLA) demonstrating biosimilarity to the reference product without necessitating the same level of clinical data as a new biologic.
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