ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products

ARLINGTON, Va., Jan. 13, 2017 /PRNewswire/ -- The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming:

We commend the FDA for its continued leadership in emphasizing the importance of distinct naming for all biologics, including biosimilars. Our members are keenly aware of the benefits biosimilars will bring to patients, including new treatment options and reduced costs. 

Yet the portion of the Guidance dealing with suffix design remains at odds with the preferences of the physicians who prescribe them and the pharmacists who dispense them, as revealed in two 2015 surveys: The Guidance specifies the distinguishing four-letter suffix be 'devoid of meaning'.

Yet when 400 U.S. biologic prescribers were asked their preference between manufacturer-based suffix such as "sndz" used in Zarxio (filgrastim-sndz), where "sndz" reflects the manufacturer, Sandoz) and random suffixes such as "bflm" (the proposed replacement of  "-sndz"), 60% of prescribers preferred the manufacturer-based format. (9% preferred random, and 32% had no opinion.) Among the 401 pharmacists surveyed, this preference for meaningful, memorable suffixes was even stronger: 77% preferred the manufacturer-based suffix, 15% the random suffix, and 8% had no opinion.

Both groups of providers responded that manufacturer-derived suffixes were easier to recognize and remember, easier to reorder, and that they held manufacturers accountable for their products.

It remains ASBM's position that incorporating a suffix based on the name of the initial manufacturer or marketing authorization holder at the time of approval would promote the most meaningful, memorable, intuitive, and informative method of distinguishing similar biologic products from their reference products and one another. Further, it would better promote accountability by efficiently associating the product with the legal entity ultimately responsible for its production, safety, quality, and efficacy.

Unlike generic versions of chemical drugs, biosimilars are not exact duplicates of their reference products and these differences can result in unexpected effects including reduced efficacy or unwanted immune responses. Therefore, clear product identification of all biologics, including biosimilars, is critical for healthcare providers, patients, and regulators to avoid inadvertent substitution, and to accurately attribute any adverse events to the correct product.

The physicians surveyed support the FDA's issuance of distinct names for all biologics, including biosimilars by a factor of 6-to-1. (66% support, 11% oppose, 23% expressed no opinion).  Similarly, an October 2015 survey of 401 U.S. pharmacists showed 68% supported the FDA issuing distinct names for all biologics, including biosimilars.