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Physicians Groups Commend FDA Biosimilar Labeling Guidance, Make Recommendations
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Eight groups representing biologic prescribers commended the FDA’s draft guidance on labeling biosimilar products and offered recommendations for additional provisions, according to a press release.
Those groups included 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.
The FDA’s draft guidance “Labeling for Biosimilar Products” addressed the continued emergence of biosimilar agents, which can allow greater access to therapeutic options but are not identical to their reference product in the same way generics are.
In their letter to the FDA commissioner, the physician groups requested that the final guidance include the FDA’s plans for labeling biologic and biosimilar transitional products, and they recommended that labels on biosimilar products include the following:
Indication of whether the biosimilar is interchangeable with other products, including the reference product and other biosimilars;
A hyperlink to or summary of the full clinical data submitted to support approval of the biosimilar; and
Both the proprietary and nonproprietary names of the biosimilar and reference biologic on all mentions.
“We thank the [FDA] for its thoughtful draft guidance ‘Labeling for Biosimilar Products’ that makes important distinctions between the labeling needed for a biosimilar and a generic drug, especially for adding in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,” the physician groups wrote. “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.”