NORD Advises FDA On Biologics Naming Policy
The U.S. Food and Drug Administration (FDA) received a letter from the National Organization for Rare Disorders (NORD) urging Commissioner Margaret Hamburg and the agency to consider the potential implications of its biologics naming policy on rare disease treatments.
More than 7,000 rare diseases have been identified in the U.S., affecting an estimated 30 million Americans. In its letter, the National Organization for Rare Disorders (NORD) proposed that the FDA adopt unique, individual names for biologics, including biosimilars, in order to protect patients from confusion about treatment options and increased adverse events.
“Our position stems from the existing lack of consistent naming protocols for biologics and the potential for significant physician and patient confusion once biosimilars become available. The need for distinguishable names is independent of FDA's latest guidance on levels of evidence of biosimilarity,” NORD stated in its letter to the FDA.
The letter argues that distinguishable naming of each biologic is critical to help health care professionals to recognize and deliver the proper degree of personalized medical care for patients with rare diseases. According to NORD, taking this step would:
- Support the medical community's crucial post-approval learning curve about the proper medicines that would fit patients with rare diseases;
- Encourage monitoring and tracking of adverse events, in view of rare disease patients’ unpredictable and less studied response to medications compared to other patients;
- Promote distinction in the biosimilars law between biosimilars (similar not identical) and interchangeable biosimilars (similar but observed to show comparable clinical results)
NORD President and CEO Peter L. Saltonstall, said, “Every patient deserves the care best suited for their medical situation and most likely to give them the best outcomes. Biologics are often the most advanced and effective treatments for patients we represent and everyone in the treatment continuum should be able to readily identify the specific drug product a patient was given.”
The FDA has not yet issued a response to the letter from NORD.