Unlike generic medicines, biosimilars have a different, abbreviated regulatory pathway to approval. 2

Biosimilars are often confused with generic medicines — but they are not exactly the same. 1-3

  • Generic medicines are chemically synthesized while biosimilars are grown in complex living systems 2,4
  • Biologic medicines are large, complex molecules or mixtures of molecules that may be composed of living material — as such, biosimilars are unlikely to be exact copies of their reference products 2,4
  • Unlike generic medicines, the FDA requires a biosimilar to be highly similar, but not identical to the existing biologic medicine, or “reference product” 2,5,8
  • A biosimilar also must demonstrate no clinically meaningful differences in efficacy, safety, and potency with its reference product 8
  • Biosimilars are reviewed and approved under the abbreviated FDA review process known as the 351(k) pathway 2
  • Per FDA guidance, the Agency reviews the totality of evidence and does not necessarily focus on one type of study to evaluate a manufacturer's application for demonstration of biosimilarity 6
  • The manufacturer of a biosimilar demonstrates biosimilarity primarily from nonclinical analyses in a stepwise approach that includes examining the structure and functional nature of the biosimilar molecule 2,5

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