Biosimilars need better labeling: Physicians

May 22, 2015

In FDA's 2012 Draft Guidance on Biosimilars, the Agency called for "labeling of a proposed product to include all the information necessary for a health professional to make prescribing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.

Eight physician groups urged FDA to ensure that biosimilar product labeling contains all needed data for physicians to make appropriate prescribing decisions for their patients.

The 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 sent a letter to FDA Commissioner Stephen Ostroff late last week.

Related: FDA issues biosimilars final guidance

The groups are concerned that the first US biosimilar approved, Zarxio (filgrastim-sndz), has the identical data package to its reference product and does not include statements of biosimilarity or interchangeability.

"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,” according to a statement from the groups, Biologics Prescribers Collaborative.

In FDA's 2012 Draft Guidance on Biosimilars, the Agency called for "labeling of a proposed product to include all the information necessary for a health professional to make prescribing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.

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, according to the BPC.

“Further, given that a biosimilar – unlike a generic small molecule – has its own clinical data, there will likely be specific information from this data package that will help physicians, including the provision of information on immunogenicity, which can vary from the reference biologic,” the letter stated. “As such, we urge FDA to give full consideration to what elements of the biosimilar data package would be helpful to physicians.”

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