At Genentech, we have long supported the FDA’s efforts to implement a science-based pathway for the approval of biosimilars. As an experienced manufacturer of biologic medicines, we’re committed to providing healthcare professionals with factual and balanced information on both biologic and biosimilar medicines. The availability of more treatment options is good for patients and we believe that patients and their physicians should have a choice in the medicines that they receive.

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.

Dr. Gregory Schimizzi explains how a biosimilar can be used for an unevaluated indication

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

Dr. Andrew Zelenetz shows differences between biosimilar and its counterpart

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 being approved for some, or potentially all its reference product’s indications — based on scientific justification — 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.