By Amanda Conschafter, blog editor
A group of specialty physician societies and members of AfPA’s National Physicians Biologics Working Group made a collective appeal to the Food and Drug Administration today for giving biosimilar follow-ons distinct names. In a multi-signatory letter to FDA Commissioner Margaret Hamburg, rheumatologists, neurologists, neonatologists and urologists – as well as nearly a dozen medical associations and physician groups – offered a unified opinion on biosimilar naming. The matter has elicited increased attention in recent weeks as the FDA considers its first biosimilar approval applications.
As physicians who regularly prescribe biologics and treat patients suffering from the complex diseases they treat, the signers offered insight on several facets of the naming issue. First, the physicians noted, distinct names will alert physicians that “each product, while safe and effective, may differ slightly.” That clarity will allow physicians to confidently, accurately prescribe the therapy best suited for each patient.
Distinct names also dispel confusion about which indications correspond to which biologic medications. Identical names, the physicians explained in their letter, would suggest that biosimilars had been tested and approved for the same indications as had their biologic reference products. But such is not always the case. Confusion on the issue of indication approval could also undermine the FDA’s decisions on interchangeability; identical names would suggest interchangeability regardless of the FDA’s official decision on the matter.
Finally, distinct names would aid the cause of pharmacovigilence, physicians argued. Considering biologic medicine’s molecular size and complexity, as well as its effects on immunogenicity, physicians and regulators should be able to quickly, accurately trace adverse events back to their origin.
Noting that some opinions on biosimilar naming originate from physicians who “may never prescribe a biologic,” these specialists offered their suggestions based upon first-hand experiences with patients. For these patients, some severely ill, biologics offer unparalleled promise, the physicians explained. “These innovative therapies can be lifesaving,” the letter’s signers noted, cautioning “but they are also complex.”
The signatories to the letter include:
- Alliance for Patient Access
- American Academy of Allergy, Asthma & Immunology
- American Academy of Dermatology
- American Academy of Neurology
- American Association of Clinical Endocrinologists
- American College of Rheumatology
- American Urological Association
- Association of Black Cardiologists, Inc.
- Clinical Immunology Society
- Coalition of State Rheumatology Organizations
- North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.
Read the letter in full here.
