FDA Takes Steps to Refine Biosimilar Naming Convention

March 8, 2019

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

On March 7, 2019, FDA Commissioner Scott Gottlieb, MD, announced an update to FDA’s policy for determining the naming convention for biosimilars in an effort to balance competition on the market and help ensure patient safety.

The agency is releasing a draft guidance to explain that:

  • It no longer intends to modify the proper names of biological products that have already been licensed or approved under the Public Health Service Act without an FDA-designated suffix in their proper names.

  • The agency does not intend to apply the naming convention to the proper names of transition biological products.

  • Going forward, for interchangeable biosimilars, FDA intends to designate a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.

Gottlieb states that this framework will help secure pharmacovigilance so that the agency can effectively monitor all biological products in the post market-originators and biosimilars-and promote patient safety. To facilitate adverse event-report tracking, originator, biosimilar, and interchangeable products will have nonproprietary names that are distinct from each other.

“Additionally, under this updated policy, any product that is first licensed as a biosimilar and later determined to be interchangeable will keep its nonproprietary name after receiving a determination of interchangeability,” Gottlieb said in an FDA statement. “The naming policy will provide consistency among biologics and will help ensure health care providers and patients have confidence in the safety and effectiveness of any biological product on the market.”

To meet these goals, the unique four-letter suffix that is incorporated as part of a biological product’s nonproprietary name is being applied to originator products going forward, as well as to any biosimilar and interchangeable products. This will allow each product to be appropriately distinguished from one another at the pharmacy level.

“Because biologics are generally complex and typically impossible to replicate in the way small-compound drugs can be, and even though biosimilars have no clinically meaningful differences from the reference product, these unique suffixes are a critical component of FDA’s ability to track adverse events to a specific biological product and manufacturer so that appropriate action can be taken when needed to protect patients,” Gottlieb stated.

Policy for safety

The naming convention is meant to ensure patient safety by helping providers and patients properly identify products where a distinction between each product is important to know, especially between different versions of similar or interchangeable products. As it stands, the proper names of all 17 approved biosimilars have been approved with the four-letter suffixes, as have the proper names of 27 originator biological products. As FDA continues to apply the policy, it is expected that there will be a steadily increasing proportion of licensed biological products, including originator products, that will have nonproprietary names that include four-letter suffixes. Of the biological products within the scope of the policy, only those originator products licensed prior to the implementation of the policy will lack a suffix, the commissioner noted.

“To go back and change the names of these approved products would be a costly enterprise to the health care system; 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. Moreover, requiring retrospective name changes would not help advance the interest of effective pharmacovigilance since these products are already generally distinguishable by their proper names. So, [FDA] is not requiring these legacy names to be changed,” Gottlieb said.

The policy update follows the January 2017 release of an FDA guidance document in which the agency sought to balance concerns over biologic-product name distinction by using a distinguishing suffix to the proper names of biological products, including not just biosimilars, but originator products as well. “By applying this policy to originator and biosimilar products alike, [FDA] sought to advance the goal of patient safety-which the suffixes promote-without creating a misimpression that products with such suffixes are somehow inferior to those without. In addition, [FDA] announced in that guidance that the agency was considering the process to retrospectively change the names of biological products already on the market, to begin adding distinguishable suffixes,” said Gottlieb.

“Today’s updated draft guidance sets a clear path for the nonproprietary naming of interchangeable biosimilars. The feedback the agency previously received as part of the comment period for the final 2017 guidance raised important concerns on the part of industry. With today’s announcement, we hope to receive additional public input. Based on the comments received for today’s draft guidance, we intend to ultimately issue a revised, final version of the 2017 Nonproprietary Naming of Biological Products guidance that amends the relevant sections necessary to incorporate input we receive through this comment period,” he added.

The new naming policy is aimed at a March 2020 transition, when the biosimilar and interchangeable pathway will open to additional products, such as insulin. The agency is also taking additional steps to promote competition and access. In July 2018, it announced the Biosimilars Action Plan to help advance its implementation of the Biologics Price Competition and Innovation Act, a key component of which is improving the efficiency of the biosimilar and interchangeable product development and approval process. The plan also seeks to increase scientific and regulatory clarity for the biosimilar development community.

In addition, in December 2018, the agency announced a suite of new policy actions advancing this plan, including new guidance describing the agency’s approach to the statutory transition of approved applications for biological products currently regulated under new drug applications to being regulated under biologics license applications on March 23, 2020. “This important milestone will enable, for the first time, products that are biosimilar to, or interchangeable with these transitioned biological products-like insulin-to come to market,” Gottlieb remarked in his statement.

Gottlieb also said that, alongside the new naming convention policy for biologics and biosimilars, the agency is also carefully considering applying the naming convention to vaccines. In view of the existing framework for ensuring safety reporting and monitoring for vaccines, the agency is considering whether the information that’s already available through identification systems associated with the administration of vaccines is sufficiently robust for ensuring pharmacovigilance such that the agency may not need distinguishable proper names with suffixes for vaccines.

Source: FDA