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 We are releasing an updated draft guidance that explains that: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, ...
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