Making appropriate decisions for your patients requires knowledge of the FDA’s guidance on biosimilars. There are many things to understand — including the concept of interchangeability.
Biosimilars: Meet the Experts
Four medical experts share their insights on biosimilars — including interchangeability, the abbreviated regulatory pathway, indication extrapolation, and labeling — to help physicians, pharmacists, and patients make informed treatment decisions.
Biosimilar Interchangeability: An Evolving Designation
Dr. Field explains the effect of interchangeability — a designation unique to biosimilars — on the decision-making of physicians and pharmacists relative to substitution. To date, the interchangeability designation has not been granted to any biosimilar in the United States. 9,12
Biosimilars vs Generics: Similar but Not the Same
Unlike with generics, the FDA requires that a biosimilar be “highly similar” to the existing biologic reference product with no clinically meaningful differences in safety, purity, and potency. Dr. Morse breaks down the abbreviated regulatory pathway granted to biosimilars. 2,8
Indication Extrapolation: A Different Pathway to Approval
“Extrapolation” refers to a biosimilar — based on scientific justification — being approved for some, or potentially all its reference product’s indications even if they were not evaluated during the biosimilar’s clinical trials. 2 Dr. Schimizzi clarifies the concept.
The Biosimilar Label: Why You Will Generally Not See the Biosimilar’s Data
Biosimilar labels generally do not include the clinical data used to establish biosimilarity. Instead, biosimilar labels contain clinical data from their reference product. 8 Dr. Zelenetz explores the implications for prescribing biosimilars.