Biosimilar News (05/22/2015)

In a letter to Food and Drug Administration (FDA) Commissioner Stephen Ostroff, eight groups representing physicians who prescribe biologics called for biosimilar product labeling to contain all the data physicians need to make appropriate prescribing decisions. "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," the letter says. It adds that drug labels must be "complete and accurate." Some groups are concerned that the biosimilar Zarxio (filgrastim-sndz) has the identical data package to its reference product and does not contain statements of biosimilarity or interchangeability. Prescribers may mistakenly think that an identical label means that a biosimilar is interchangeable with the reference product and has approval for all of the same indications--but this is not necessarily the case with biosimilars. The letter was sent by 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.

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