Robert M. Califf, M.D.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
RE: Comment on Food and Drug Administration Draft Guidance “Labeling for Biosimilar Products; Draft Guidance for Industry; Availability” [Docket ID FDA-2016-D-0643-0003]
Dear Commissioner Califf:
As members of the Biologics Prescribers Collaborative (BPC) and professional organizations with biologics prescribers, we welcome the availability of biosimilars in the U.S. Biosimilars will provide greater access to more therapeutic options for the thousands of patient who rely on biologic medicines.
We thank the U.S. Food and Drug Administration (FDA) for its thoughtful draft guidance “Labeling for Biosimilar Products” that makes important distinctions between the labeling needed for a biosimilar and a generic drug, especially for adding in a statement of biosimilarity. We believe the label of a biosimilar product should be transparent and facilitate access to data used in support of the biosimilar application. Doing so will build prescriber confidence in this new class of medicine which is paramount to a successful biosimilars market.
To that end, we ask FDA to consider these additional provisions in its final guidance, which promote transparency and, ultimately, are essential to upholding patient safety:
- The label should include a statement of whether the biosimilar is interchangeable with the reference product and/or other biosimilars on the market. We know that many health care providers will confuse a finding of biosimilarity with a finding of interchangeability. Explicit labeling and transparent communications are needed to ensure the appropriate use of biosimilars in accordance with the statute.
- The label should provide either a summary of the full clinical data submitted in support of biosimilar approval or a hyperlink to the FDA’s summary basis of approval. As prescribers, we know physicians will have questions about the data used to support a biosimilar’s approval. This becomes especially important regarding the indications for which the biosimilar is approved to treat and/or immunogenic effects.
- The label should ensure that all mentions of either the reference biologic or the biosimilar should include both the proprietary name (if available) and the non-proprietary name. As prescribers, we believe that pharmacovigilance is best achieved through the use of memorable and distinguishable non-proprietary names for all biologics. In contrast, FDA’s decision to use a four letter randomized suffix when approving the second biosimilar (infliximab-dyyb) raises concerns and we would like FDA to consider and prioritize patient safety by requiring meaningful and distinguishable names, such as the manufacturer’s name.
- The final guidance should indicate how FDA plans to address labeling for biologic and biosimilar transitional products, originally approved as drugs under the Federal Food, Drug and Cosmetic Act (FDCA), that will be replaced as a licensed biologic under section 351(a) or 351(k) of the Public Health Service Act (PHSA) by March 23, 2020. Currently, it is unclear how the agency will address discrepancies between the labeling requirements under FDCA and PHSA. As this transition occurs, we believe that the labeling for these products should be clear, consistent and contain complete information to ensure prescribers are able to make the best treatment decisions for their patients.
The product label is a critical tool for physicians to make the best prescribing decisions and we commend FDA for its careful consideration of the guidance needed to optimize the biosimilar label. We request the Agency finalize its guidance to support fully transparent and clear labels for biosimilars.
Alliance for Patient Access
American Association of Clinical Endocrinologists
American College of Rheumatology
American Gastroenterological Association
Biologics Prescribers Collaborative
Coalition of State Rheumatology Organizations
North American Society for Pediatric Gastroenterology, Hepatology and Nutrition
Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research
Dr. John Jenkins, Director, Office of New Drugs, Center for Drug Evaluation and Research
Dr. Leah Christl, Associate Director, Therapeutic Biologics
Dr. Steven Kozlowski, Director, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research