Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's steps on naming of biological medicines to balance competition and safety for patients receiving these products

We're at a critical point for the future of biosimilars in the U.S. Millions of American patients stand to benefit from increased utilization of these lower-cost, high-quality products. At the FDA, we're committed to helping patients realize the public health benefits of a robust, competitive market for biosimilars.

Since the biosimilar pathway was established in 2010, there's been debate about how biological products should be named, and whether a unique identifier such as a distinguishing suffix should be added to the proper (i.e., non-proprietary) names of biological products to help ensure strong pharmacovigilance. Some have argued that the addition of a distinguishing suffix could serve as a barrier to the use of biosimilar products and brisk competition. We strongly believe in the ability of biosimilars to promote competition, lower prices and foster greater access. And we're fully committed to the suite of announced and upcoming policies to help advance the goal of a robust, high-quality, competitive market for biosimilar products. But I do not believe that the naming convention should be used to advance these goals if it could come at the expense of the ability to ensure patient safety. Nor do I believe the inclusion of a suffix will frustrate the broader aim of inspiring strong biosimilar competition.

In January 2017, the FDA published a guidance document in which we sought to balance these concerns 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, the 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, the 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.

Today we're announcing an important update to our policy with respect to the naming convention. We are releasing an updated draft guidance that explains that:

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

Going forward, for interchangeable biosimilars, the 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.

This framework will help secure pharmacovigilance so that the FDA can effectively monitor all biological products in the post market – originators and biosimilars – and promote patient safety. To aid in 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.

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 achieve these goals, the unique four-letter suffix that's 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, so they can 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 the 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.

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. 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 the FDA continues to apply this policy, we expect that a steadily increasing proportion of licensed biological products, including originator products, 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.

After the FDA issued its 2017 guidance on biologics naming, we heard the concerns from stakeholders that one aspect of the policy – changing the names of older biologics to add suffixes – would impose substantial costs on the health care system and had the potential to create confusion that could increase risks to patients as drug names don't often change after drugs go to market. After careful consideration, the FDA has determined that the crucial public health goals of the naming policy could still be accomplished by applying the naming convention to newly licensed biological products, while avoiding the negative consequences raised by extending the naming convention to previously licensed products.

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 names changes would not help advance the interest of effective pharmacovigilance since these products are already generally distinguishable by their proper names. So, the FDA is not requiring these legacy names to be changed.

Ultimately, our policy on naming is meant to help ensure the safety of patients receiving biological products. We expect that by continuing to apply suffixes to new originator, related, biosimilar and interchangeable products that we will help meet our objective of safe use and pharmacovigilance. We're also issuing internal procedures for FDA staff to ensure consistency and provide transparency of the review process for suffixes for applicable products.

In advancing consistency in the convention for naming all newly licensed biologicals – be it originator, biosimilar or interchangeable products – we aim to mitigate the risk of false perceptions from health care providers and patients that there's a difference in the relative safety and effectiveness of these biological products based on their name. We expect that as time goes on, and more biological products are introduced to the market with distinguishable suffixes, patients and providers increasingly will understand that the suffixes reflect a consistent naming convention and are not an indicator of product quality. What's important to remember is that biosimilars have been proven to be highly similar and have no clinically meaningful differences, and the FDA continues to engage in efforts to promote this understanding.

The FDA has developed its naming policy with a view to the March 2020 transition, when the biosimilar and interchangeable pathway will open to additional products, such as insulin. As we look to the future, and the transition draws nearer, the agency will continue to take new steps to make the biosimilar development process more efficient and transparent. We continue working to implement the statutory transition provisions – such as transitioning certain products, including insulin, to the Public Health Service Act – in a way that minimizes burden, helps ensure stability for patients using currently marketed products, and advances the development of biosimilar and interchangeable products, opening originator biologics up to competition from biosimilars.

To advance all of these complementary goals, we are taking many additional steps to promote competition and access. In July 2018, we announced the Biosimilars Action Plan to help advance the agency's implementation of the Biologics Price Competition and Innovation Act. A key part of the plan is to improve 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 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 NDAs to being regulated under BLAs 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.

As we move closer to the 2020 transition, we know that the FDA's biologics naming policy is a component of broader efforts to help facilitate robust competition among biologics. Our primary goal with respect to the naming convention is to matters of patient safety. But, we're cognizant of – and responsive to – how these decisions impact competition and we shaped our policy with these considerations also in mind.

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.

Finally, as part of today's update, we are announcing that the agency is continuing to carefully consider the application of the naming convention to vaccines. In view of the existing framework for ensuring safety reporting and monitoring for vaccines, the agency is carefully considering whether the information that's already available to us through identification systems associated with the administration of vaccines is sufficiently robust for ensuring pharmacovigilance such that we may not need distinguishable proper names with suffixes for vaccines.

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