Physician Groups Band Together on Labeling of Biosimilars

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Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.


On May 21, 2015, eight groups of physicians sent a letter to FDA Commissioner Stephen Ostroff stressing the need for product labeling on biosimilars containing all data needed for physicians to make prescribing decisions for patients. The eight groups consisted of 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.

Unlike generics, biosimilars are not interchangeable, necessitating more information to be available for prescribers, such as indications and immunogenicity. Increased data on biosimilar labels will increase patient safety, and physician confidence in prescription. According to a press release, the letter to FDA 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."


The press release continues by referencing FDA’s 2012 Draft Guidance on Biosimilars, which requested that proposed products should include all data on the label that would assist physicians to make the decision to prescribe to a patient. The 2012 Draft Guidance included a statement on determining interchangeability between a biosimilar and its reference product. It may be beneficial for biosimilars to list data from the biosimilar and its reference biologic. Peter Pitts, former FDA commissioner, writes in a blog that on the label for the recently approved Zarxio (filgrastim-sndz), there are no references to “biosimilar” or the clinical data that led the biosimilar to be approved, leaving the label to look almost identical to the reference biologic, Neupogen (filgrastim). Pitts makes a particularly good point in that the transparency in listing data on labels would help biosimilar manufacturers gain trust and consideration from physicians and patients.

Source: PR Newswire