GPhA Responds to PhRMA/BIO’s Joint Citizen Petition Regarding Biosimilar Labeling

FDA Citizen Petition Tracker

As we previously reported, in late 2015, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations jointly submitted a Citizen Petition asking the FDA to require biosimilar product labeling to:

  1. State that the product has been approved as a biosimilar for stated indications and routes of administration and identify the reference product;
  2. Describe the basis of approval for each indication by identifying the relevant nonclinical and clinical data for the reference product and biosimilar that support a finding of biosimilarity; and
  3. State whether FDA has made a determination of interchangeability with the reference product and include any such FDA finding.

As we also reported in that same post, the UAW Retiree Medical Benefits Trust and affiliated funds (“UAW”) filed a competing Citizen Petition regarding biosimilar labeling.  UAW’s petition asks the FDA to require that all approved prescription drug labeling for biosimilar and interchangeable biological products follow the “same labeling” approach used with ANDA products and to hold a Part 15 public hearing to address labeling issues.

The Generic Pharmaceutical Association (“GPhA”) and the Biosimilars Council (a division of GPhA) recently submitted a comment opposing the PhRMA/BIO joint petition and supporting, in part, the UAW petition.

Response to the PhRMA/BIO petition

GPhA’s comment asks the FDA to reject PhRMA’s and BIO’s “thinly disguised attempt to subvert the goals of the BPCIA to increase patient access to safe, effective and affordable biosimilar and interchangeable biological products.”  According to GPhA, the labeling requirements that PhRMA and BIO propose—which “are nearly identical to those requested” in AbbVie’s related Citizen Petition—are “unnecessary and potentially confusing.”  GPhA argues that “the information and disclosures requested by BIO, PhRMA, and AbbVie are unnecessary to the safe and effective use of biosimilars and thus can be omitted in full compliance with FDA’s labeling regulations and without rendering the biosimilar’s labeling ‘materially misleading.’”  GPhA states that, because a biosimilar applicant’s clinical studies are “conducted to establish to biosimilarity” and “not to independently establish the safety and effectiveness of the biosimilar itself,” the data from those studies “generally would not be relevant to the safe and effective use of the biosimilar and thus would not be required (or, arguably, permitted) in biosimilar labeling under FDA’s existing labeling regulations.”  GPhA concludes that “the joint BIO/PhRMA CP, like the AbbVie CP before it, seeks to impede the adoption and use of biosimilar and interchangeable biological products by requiring their labeling to include unnecessary and confusing information that misleadingly suggests to healthcare professionals that such products have clinically meaningful differences from their RPs in terms of safety, purity, or potency when, in fact, they do not.”

Response to the UAW petition

With regard to the “same labeling” approach proposed by UAW, GPhA only “supports the UAW CP to the extent it recognizes that biosimilar labeling may be the same as the RP labeling, but GPhA does not agree that this is required by the BPCIA.”  According to GPhA, the BPCIA permits, but does not require, biosimilar labeling to be the same as the reference products labeling.  GPhA notes that “given the statutory requirement that a biosimilar must be ‘highly similar’ to a RP – with no clinically meaningful differences in terms of safety, purity, or potency – biosimilar labeling will closely track the labeling for the RP.”

GPhA opposes UAW’s request for a Part 15 hearing because holding such a hearing “could delay FDA’s issuance of a final guidance document on biosimilar labeling.”  Instead, “GPhA supports FDA’s issuance of its planned guidance document, which will allow public feedback on this issue.”

Stay tuned to the Big Molecule Watch for further updates on the biosimilar labeling issue.

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