FDA's Updated Biosimilar Naming Convention Stirs Concern in Industry

The FDA recently published an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars.

In an updated draft guidance on the naming convention of biologics, biosimilars, and interchangeable biosimilars, the FDA announced it no longer intends to retrospectively assign suffixes to already-approved biologics. However, the agency will continue to add distinguishing 4-letter suffixes to the proper names of biological products to ensure “strong pharmacovigilance.”1

The guidance also states that the agency does not intend to add suffixes to the names of transition products, such as insulin. For interchangeable biosimilars, the FDA will designate a proper name that is a combination of the core name and a distinguishing 4-letter suffix that is devoid of meaning.

Dr Gottlieb said in a statement that the draft guidance represents the FDA’s attempt at balancing concerns expressed by industry stakeholders. He noted that the agency recognized that adding suffixes to the names of already-approved biologics would be costly to the health care system.1

“If those costs were to be passed on to patients, that impact would run directly counter to the goals of access and affordability that underlie the biosimilars program,” he said in a press release.1

Regarding the agency’s decision to continue with the suffix naming convention to newly-approved products, Dr Gottlieb explained that, “The naming convention is meant, first and foremost, to ensure patient safety by helping providers and patients properly identify products where it’s important to be able to distinguish between different medicines and different versions of similar or interchangeable products.”1

However, industry stakeholders view the naming convention as problematic and as a hindrance to the biosimilar market. The Biosimilars Forum told The Center for Biosimilars that it considers the updated draft guidance “a direct blow to biosimilars uptake” in the United States. According to The Centers for Biosimilars report, the agency’s reversal in its plan to retrospectively add 4-letter suffixes to already approved biologics will lead to misconceptions that strict pharmacovigilance applies only to biosimilars.2

Christine Simmon, executive director of the Biosimilars Council, a division of the Association for Accessible Medicines (AAM), said in a prepared statement that, “AAM is reviewing the FDA’s new draft guidance on biosimilar naming requirements and will submit comments to the docket. FDA’s current requirement of suffixes presents a significant, artificial barrier to biosimilars that is misaligned with the agency’s own Biosimilars Action Plan and the Trump administration’s commitment to lowering drug prices for American’s patients.”3

Ron Lanton III, Esq, executive director and senior counsel for Frier Levitt Government Affairs, wrote in an email to Specialty Pharmacy Times that the guidance shows the FDA’s commitment to its March 2020 transition, when additional products will be open to the biosimilar and interchangeable pathway.

“I know of several stakeholders with questions about the logistics described within the guidance,” Lanton wrote. “I do think there is an opportunity to address several brewing concerns around this issue via the pending comment period. However, it will be interesting to see how this issue develops, especially in light of Dr Gottlieb’s recent resignation.”

In addition, the FDA is implementing an internal procedure for staff to ensure consistency and transparency in the review process for suffixes. The agency also announced that it is considering its naming convention for vaccine products, too.1

The FDA will receive comments on the draft guidance over the next 60 days and intends to issue a final version in the future.

References

  • Statement from FDA Commissioner Scott Gottlieb, MD, on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products [FDA statement]. FDA. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632870.htm. Accessed March 8, 2019.

  • Davio K. Developers Call FDA Guidance on Suffixes a “Direct Blow” to Biosimilars. Published March 8, 2019. https://www.centerforbiosimilars.com/news/developers-call-fda-guidance-on-suffixes-a-direct-blow-to-biosimilars. Accessed March 8, 2019.
  • AAM Statement on FDA Draft Guidance on Biosimilar Naming Requirements. Association for Accessible Medicines. https://accessiblemeds.org/resources/press-releases/aam-statement-fda-draft-guidance-biosimilar-naming-requirements. Accessed March 8, 2019.