On Tuesday, August 2, 2016, eight groups representing a broad spectrum of biologic prescribers – Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, American Gastroenterological Association, Biologics Prescribers Collaborative, Coalition of State Rheumatology Organizations, Endocrine Society, and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition – commented on the U.S. Food and Drug Administration's (FDA) draft guidance "Labeling for Biosimilar Products; Draft Guidance for Industry; Availability", commending the agency on acknowledging the distinctions between the labeling needed for a biosimilar and a generic drug, especially for adding in a statement of biosimilarity.
The comment letter states that "the label of a biosimilar product should be transparent and facilitate access to data used in support of the biosimilar application." As such, the physician groups urge FDA to consider additional provisions in its final guidance to enhance transparency and patient safety. Requested enhanced provisions include:
- The label should include a statement of whether the biosimilar is interchangeable with the reference product and/or other biosimilars on the market.
- 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.
- 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.
- 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.
As biosimilars continue to emerge on the market, providing additional therapeutic options to patients, and due to the product label being a critical tool for physicians to make the best prescribing decisions, the groups call for FDA to give full consideration to the needs of physicians when considering future labels.
As such, the groups urge for FDA to consider these provisions that will "build prescriber confidence in this new class of medicine" by providing all needed data for physicians to make appropriate prescribing decisions for their patients.