January 12, 2017 BPC Statement Applauding FDA for Distinguishable Biologics Naming; Disappointed in ‘Random’ Suffix

The Biologics Prescribers Collaborative (BPC) applauds the U.S. Food and Drug Administration (FDA) for issuing final guidance calling for distinguishable names for all biologic medicines. This policy is an important win for patients and physicians because distinguishable naming is essential for pharmacovigilance, patient safety and transparency.

However, as the BPC has voiced to FDA, we remain concerned with  “random” suffixes called for in this guidance. As physicians who routinely prescribe biologic medicines, we believe a memorable suffix is needed. One that reflects the manufacturer of the medicine is immediately recognizable and would facilitate prompt, accurate adverse event reporting by patients and physicians to the correct manufacturer and that manufacturer’s mandated reporting to FDA. Furthermore, a randomized four-letter code may complicate the achievement of FDA’s goal to improve pharmacovigilance and prevent inadvertent substitution.

In early November, BPC released findings of a SERMO poll representing physicians across multiple specialties. 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 appreciate FDA’s careful consideration of this important issue. 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.

The Biologics Prescribers Collaborative is an organization of groups representing physicians who regularly prescribe biologics that aims to ensure that sound policies are in place to promote the safest possible use of all biologics, including biosimilars, for all patients.

Stay Informed View the latest newsletter

To receive regular newsletters and periodic alerts from the BPC, enter your email address in the form below: