Speeches & Communication

PhRMA comments to FDA on Biosimilar Labeling

PhRMA August 8, 2016

PhRMA is pleased to provide comments on the Food and Drug Administration's (FDA) Draft Guidance for Industry: Labeling for Biosimilar Products. PhRMA supports the Draft Guidance in several respects, including the proposed recommendation that biosimilar labeling should state that the product has been approved as a biosimilar for stated indications and identify the reference product. We believe, however, that biosimilar labeling also should:

  1. Describe the basis for approval for each indication by identifying the relevant data for the biosimilar that support a finding of biosimilarity; and
  2. State whether or not FDA has made a determination of interchangeability with the reference product and include any such FDA finding.

PhRMA recommends that FDA revise the Draft Guidance accordingly to ensure that biosimilar labeling provides health care professionals with appropriate regulatory transparency and to facilitate informed choices by health care professionals and patients.