Stephen Ostroff, M.D.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
RE: Comment on Food and Drug Administration Guidance “Nonproprietary Naming of Biological Products” [Docket No. FDA-2013-D-1543]
Dear Acting Commissioner Ostroff:
As members of the Biologics Prescribers Collaborative (BPC) and professional organizations with biologics prescribers, we support sound policies that promote the safe use of biologics, including biosimilars, for all patients. We applaud the Food and Drug Administration (FDA) for recognizing in its “Nonproprietary Naming for Biological Products” guidance that each biological product needs a distinguishable non-proprietary name, including previously approved originator drugs.
As FDA considers the naming nomenclature for interchangeable biosimilars, BPC members urge FDA to ensure this policy is applied to these medications. Distinguishable names for biological products foster pharmacovigilance through a detailed ability to track adverse events, a necessary step to preserve patient safety.
FDA’s final guidance states that all biological products will bear a nonproprietary name that is a combination of a core name and a four-letter suffix, devoid of meaning. However, as BPC has voiced previously, biologics prescribers tell us that the suffix should be memorable, which cannot be easily accomplished when it is meaningless. BPC recently released findings of a SERMO* poll representing more than 500 physicians across multiple specialties and found that overwhelmingly, 80 percent of physicians preferred a meaningful four-letter suffix that noted the biosimilar manufacturer’s name, versus a random four-letter suffix. Only eight percent of physicians preferred a suffix devoid of meaning while 12 percent had no preference.
We remain concerned that randomized four-letter codes may complicate the achievement of FDA’s goal to facilitate pharmacovigilance and prevent inadvertent substitution. The agency noted that “FDA aims to track adverse events to a specific manufacturer…and identifying a biological product’s manufacture can help target remedial action.” An immediately recognizable suffix reflecting the manufacturer’s name would facilitate prompt, accurate adverse event reporting by patients and physicians to the correct manufacturer, and that manufacturer’s mandated reporting to FDA.
A memorable suffix could identify the license-holding manufacturer, which would be easily memorized by those who frequently prescribe biologics. Further, such a suffix would better equip patients, physicians and pharmacists to accurately recall or ascertain specifics about the biosimilar that may differ from those of the originator, such as approved indications, administration routes, or delivery systems.
While we had hoped for meaningful naming, we do appreciate FDA’s careful consideration of this important issue and the requirement of distinct names. As we gain real-world experience using these new medicines, we look forward to working with the agency to amend policies where we can achieve greater patient benefit and safety, including potentially evolving to a “meaningful” suffix.
We restate our support for FDA’s requirement that all biological products bear a distinguishable four-letter suffix to their nonproprietary names and encourage the agency to extend this policy to interchangeable biosimilars as well.
Finally, the undersigned organizations strongly support FDA’s sole authority over the identity (name) and quality standards for biologic products, including biosimilars. Acknowledging the complexity of biologics and biosimilars to that of chemically-made drugs, Congress passed the Biologics Price Competition and Innovation Act (BPCIA), which created a unique regulatory framework for the approval and safe use of biosimilars, including the naming of the products. Allotting the United States Pharmacopeia (USP) authority over the naming of biologic products could severely interfere with the safe use and adequate pharmacovigilance of biosimilars as they emerge onto the market.
Thank you for your consideration. Please do not hesitate to reach out to any of the undersigned organizations, should you require additional information.
Alliance for Patient Access
American Association of Clinical Endocrinologists
American Gastroenterological Association
Biologics Prescribers Collaborative
Coalition of State Rheumatology Organizations
*SERMO is the largest global social network exclusively for doctors
i FDA, Nonproprietary Naming of Biological Products; Guidance for Industry; Availability, Federal Register, January 13, 2017.