On March 7, 2019, the U.S. Food & Drug Administration (FDA) released updated draft guidance announcing that it will create special names for biosimilar products to distinguish them from previously approved biologic products.  Specifically, the guidance 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.

According to the FDA’s press release, “[t]his 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.”

The FDA’s biosimilar naming guidance issued in 2017 has been criticized by brand name and biosimilars manufacturers, as well as pharmacy groups, for multiple reasons. Requiring a random four-letter suffix is argued to create financial burdens and wreak havoc on tracking and billing systems. Requiring a different non-proprietary name for a biosimilar having the same active ingredient as the reference biologic is argued to thwart competition by creating confusion and distrust among providers and patients, and potentially preventing substitution with biosimilars.  The Federal Trade Commission (FTC) issued a statement in 2015 explaining that “the FDA draft guidance on biosimilar naming may hinder competition, and [the FTC] recommends that the agency consider alternatives.”  The FTC commented that the FDA’s naming convention departed from the FDA tradition, and risked causing physicians to believe mistakenly that the suffix-labeled biosimilar have clinically meaningful differences from the branded biologic products, which would potentially result in reduced price competition in biologic drug markets.  Further, the FTC noted that the naming proposal risked creating unnecessary costs, and conflicted with efforts toward global naming harmonization.

Biosimilars manufacturers have criticized the 2017 guidance for allowing random suffixes that are not uniquely tied to biosimilar company names.  Industry also criticized the proposed retroactive application of the guidance, which has now been nixed by the March 2019 guidance.  By nixing the retroactive application of the guidance, the FDA has awarded a further win to brand biosimilar manufacturers given that all biosimilar versions of currently-approved biologic products will be designated using suffixes, while the names of all currently approved brand products will remain unchanged.  As such, critics will argue that the FDA has not ensured that there is a level playing field for biosimilars manufacturers of products that are intended to increase price competition in biologic drug markets, which account for 40 percent of U.S. pharmaceutical sales and generate annual sales of over $50 billion in the U.S.

The FDA’s stated position is that this new 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.

To date, the FDA explains that 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. FDA expects that a steadily increasing proportion of licensed biological products, including originator products, will have nonproprietary names that include four-letter suffixes.  Going forward, only those originator products licensed prior to the implementation of the policy will lack a suffix.  The FDA’s goal with this naming policy is primarily 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.

In response to concerns from stakeholders that changing the names of older biologics to add suffixes would impose substantial costs on the health care system and has the potential to create confusion that could increase risks to patients as drug names do not often change after drugs go to market, the FDA states that it believes “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.”  As such, the FDA agrees that going back to retroactively 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, the FDA agrees that requiring retrospective names changes would not help advance the interest of effective pharmacovigilance since these products are already generally distinguishable by their proper names. As such, the FDA has decided that it will not require the legacy names to be changed.

The FDA will receive comments on the draft guidance over the next 60 days with a view toward issuing a final version of the guidance in the future.