FDA Review and Approval Process for Biosimilar Medications
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FDA Review and Approval Process for Biosimilar Medications
A biosimilar is a biologic that is highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency (safety and effectiveness) from an existing FDA-approved biologic, called a reference product. All FDA-approved biologics undergo a rigorous evaluation so that health care providers and patients can be ...
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