ACR commends FDA draft guidance on biologic therapies, biosimilar names

The American College of Rheumatology has announced its support for the recently released FDA draft guidance regarding a methodology for nonproprietary naming of biologic and biosimilar therapies.

The draft guidance advocates the use of a nonproprietary substance name followed by a four-letter suffix that is unique to each product and manufacturer to avoid inadvertent substitution. The American College of Rheumatology (ACR) previously issued a position statement which included support for distinctive names that would distinguish the biosimilar agent from its originator substance.

“The ACR commends the FDA’s proposal to require distinctive names for biosimilar drugs and original biologics,” Douglas W. White, MD, chair of the ACR’s Committee on Rheumatologic Care, stated in a press release. “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The FDA’s draft guidance also included provisions to rename biologic medications that have already been approved for certain indications. A public comment period is open until Oct. 27, 2015, after which the FDA will begin the development of the final guidance.

“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,” White said.

Reference: www.rheumatology.org