Biosimilars and Their Place in Therapy

A biosimilar is a biological product that is “highly similar” to an FDA-approved reference biological product and has no “clinically meaningful differences.” Each biosimilar, with its distinct data package, approved indications, and routes of administration, offers unique and more affordable therapeutic options for patients like less costly generic drugs, however, there are differences between the two. Practitioners should understand the role of biosimilars in therapy and refer to the FDA-approved “Purple Book” to determine if a biosimilar is interchangeable with the reference biological product.

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