Physician groups pen letter to FDA urging transparency in biosimilar labeling

Eight physician groups have sent a letter to U.S. Food and Drug Administration Commissioner Stephen Ostroff, MD, to highlight the importance of ensuring patient safety by requiring transparency with biosimilar product labels.

In the letter, the groups urge Dr. Ostroff to consider the importance of ensuring biosimilar product labels contain all needed data for physicians to make safe and appropriate prescribing decisions for their patients.

The eight physician groups involved in writing the letter to the FDA are:

  • 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

The groups wrote, "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."

They also point out a some physicians may mistakenly view an identical biosimilar label as implying that a biosimilar is interchangeable with the reference product and has approval for all of the same indications — like a generic — which is not the case for many biosimilar products.

The full letter can be read here.



More articles on biosimilars:
Creating competition: Emergence of biosimilars in the U.S.
5 things to know about biosimilars
The rise of specialty drugs and healthcare costs: 6 things to know

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