Physician groups urge FDA to ensure patient safety with greater transparency in biosimilar labeling

May 22, 2015 12:24 PM

Eight groups representing a broad spectrum of physicians who prescribe biologics sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Stephen Ostroff.

In their letter, the eight groups – Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, Biologics Prescribers Collaborative, Clinical Immunology Society, Coalition of State Rheumatology Organizations, Endocrine Society, and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition – underscored the need to ensure that biosimilar product labeling contains all needed data for physicians to make appropriate prescribing decisions for their patients.

The letter states, “As FDA is aware, the label is a critical tool for physicians to both make prescribing decisions and manage potential adverse events, including side effects and drug-to-drug interactions. As such, it is of the utmost importance that any drug label be complete and accurate.”

In the FDA’s 2012 Draft Guidance on Biosimilars, the Agency called for, “labeling of a proposed product to include all the information necessary for a health professional to make prescribing decisions,” including clear statements of a product’s approval as a biosimilar to a reference product and whether or not it has been determined to be interchangeable. However, groups are concerned that the first U.S. biosimilar approved, Zarxio™ (filgrastim-sndz), has the identical data package to its reference product and does not include statements of biosimilarity or interchangeability.

Given the lack of prescriber education on biosimilars, some physicians may mistakenly view an identical label as implying that a biosimilar is interchangeable with the reference product and has approval for all of the same indications – which will not be the case for many biosimilars. Unlike generic, small-molecule drugs, biosimilars have their own unique clinical data packages, with specific information needed to help physicians to treat their patients, including the provision of information on immunogenicity, which can vary from the reference biologic.

The groups call for FDA to give full consideration to the needs of physicians when considering future labels and state that, “Greater transparency and inclusion of data will protect patients while increasing physician confidence in the use of biosimilars and encourage greater and informed utilization.”

Copies of the letter and additional information on biosimilar labeling can be found on the Biologics Prescribers Collaborative website at


Source: Biologics Prescribers Collaborative press release

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