FDA Draft Guidance Requiring Distinct Naming for Biosimilars

Biosimilar Naming Policy Will Help Ensure Patient Safety and Transparency

ATLANTA – The American College of Rheumatology (ACR) today praised the Food and Drug Administration (FDA) for issuing draft guidance requiring separate and distinct names for biosimilars and biologic therapies.

The guidance, “Nonproprietary Naming of Biologic Products,” would designate separate and distinct, non-proprietary names for originator biologic products, related biological products, and biosimilar products.

“The ACR commends the FDA’s proposal to require distinctive names for biosimilar drugs and original biologics,” said Douglas White, MD, Chair of the ACR’s Committee on Rheumatologic Care. “Distinctive names will allow for greater transparency in substitution and notification, making it clear to all parties involved – pharmacists, providers and patients – which drug the patient is receiving.”

The ACR previously issued a position statement calling on the FDA to enforce distinct names for biosimilars, and has spoken with FDA officials and submitted comment letters expressing its concerns for patient safety in instances where biosimilars are substituted without proper patient and physician notification.

Rheumatologists prescribe biologics to help patients with arthritis, lupus and other forms of rheumatic disease to manage symptoms, ease pain and avoid long-term disability. Concerns about the complexity of biologics and the potentially life-threatening adverse reactions when biosimilars are substituted without physician and patient notification have led the rheumatology community to call for stricter oversight and more transparency in the notification and substitution process.

“The FDA’s proposal to require distinguishable names for biosimilars will help rheumatologists and other specialists ensure patients continue to receive breakthrough therapies that are both clinically appropriate and effective, without compromising their health or safety,” Dr. White concluded.