Biosimilar Approval
Meaning
Biosimilar approval is the regulatory process by which a subsequent biological product is authorized for marketing based on a demonstration that it is highly similar to an already approved reference biological product, with no clinically meaningful differences in terms of safety, purity, and potency. This pathway streamlines development by relying partly on the established clinical profile of the reference product. Biosimilars offer alternative treatment options, particularly for conditions requiring complex hormonal therapies like growth hormone deficiency or diabetes management.
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