We recently posted about AbbVie’s Citizen Petition on biosimilar labeling here. We also discussed the FTC’s response to FDA’s guidance on biosimilar labeling here. In the midst of this debate, two additional organizations have recently weighed in, with petitions that stake out opposing positions on labeling.
UAW Retiree Medical Benefits Trust and affiliated funds (collectively, “UAW”) filed a Citizen Petition stating that “biosimilars and interchangeable biologics represent an attractive investment opportunity as well as a safe alternative to [costly] specialty drugs,” and asking the FDA to require that all approved prescription drug labeling for biosimilar and interchangeable biological products follow the “same labeling” approach. UAW asks FDA to hold a Part 15 public hearing to address:
- The implication of labeling rules for biosimilar innovation and investment in the U.S.;
- The European experience with biosimilars, including “same labeling,” “patient tracking,” and patient safety; and
- Stakeholder views on how different approaches to labeling may affect prescribing, dispensing, and patient user of biosimilars and interchangeable biologic products.
UAW states that, “a differentiated labeling approach for biologics and biosimilars will send an inaccurate message to prescribers that biosimilars and interchangeable biologics are more dissimilar than highly similar to each of their reference products, raising the specter of safety issues.”
On the flip side of the debate, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations filed a Citizen Petition with the FDA in hopes of making biosimilars as distinguishable as possible. PhRMA and BIO want the FDA to require that labels for biosimilar products licensed under section 351(k) of the PHSA:
- State that the product has been approved as a biosimilar for stated indications and routes of administration and identify the reference product;
- 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
- State whether FDA has made a determination of interchangeability with the reference product and include any such FDA finding.
They also request another FDA guidance on biosimilar labeling.
Stay tuned to the Big Molecule Watch for further updates on the biosimilar labeling issue.