In Comment Letters, Stakeholders Call on FDA to Change Course on Biosimilar Naming

This story had been updated.

This March, the FDA released updated guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. In the document, the FDA indicated that it no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, but it will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. In addition, FDA does not intend to add suffixes to the names of transition products.

This week, the comment period on the updated guidance closed, and the FDA heard from a variety of stakeholders who asked the agency to change its direction.

The United States Pharmacopeia voiced support of the FDA’s decision not to retrospectively assign suffixes to the names of already approved products, but said that it remains concerned that applying suffixes to newly approved products will have unintended consequences. Healthcare performance improvement company Vizient echoed that idea, applauding the decision not to require suffixes for existing biologics, but saying that suffixes for newly approved products are unnecessary and confusing.

America’s Health Insurance Plans called the FDA’s proposed naming convention a “step backward for the US biosimilars market,” and said that no products should be given a suffix in order to take a more efficient regulatory approach.

In a statement to The Center for Biosimilars^®, Susan Cantrell, RPh, CAE, chief executive officer of the Academy of Managed Care Pharamcy, went even farther, saying that, “The FDA’s updated draft guidance on biosimilars naming undermines their efforts to promote the use of biosimilars. Creating 2 separate naming conventions for the same class of products will confuse providers and reduce uptake, potentially leaving billions of dollars in savings on the table at a time when our nation desperately needs to lower health care costs.”

In its comment letter, the Leukemia and Lymphoma Society wrote that while it shares the FDA’s desire to appropriately track adverse events and collect data on the performance of biologics and biosimilars, using National Drug Code numbers, brand names, lot numbers, and a scannable bar code are sufficient to identify products and protect patient health. Adding suffixes, said the society, would create “incorrect perceptions that there are different and inferior classes of biologics and biosimilars.”

The National Kidney Foundation asked the FDA for a compromise; the foundation called on the agency to revert to its previous plan of assigning suffixes to all biologics, including already approved and marketed products. Doing so would help to ensure appropriate adverse event reporting while “creating a level playing field” for originator and biosimilar products.

Biosimilar developer Pfizer, too, saw value in giving suffixes to all biologics. Pfizer said in its letter that it agrees that biosimilars’ names should be distinguishable from their references, pointed out that suffixes are not routinely included in adverse event reports, and said that it believes that requiring suffixes for both approved and new products could increase the likelihood that suffixes would be used in this way.

It also said that failing to give already approved products suffixes could hinder market uptake for biosimilars; for example, Pfizer foresees possible “situations where a physician prescribes a product utilizing the [international nonproprietary name] without the suffix even if the intention was to prescribe a biosimilar.” The drug maker also called for meaningful suffixes linked to the drug’s license holder.

Novartis and Sandoz proposed a similar solution to Pfizer's if the agency forges ahead with its plan, writing that "if the FDA decides to continue with the implementation of a 4-letter suffix for biologic, we urge the agency to consider selective retroactive implementation to reference products of approved biosimilars and interchangeable biologics to ensure consistency." However, the companies say that suffixes are "not warranted nor desirable," and the FDA should reconsider their use entirely.

The Biotechnology Innovation Organization, however, which represents innovator biologic makers, said that the new guidance represents an important step forward with implementing the Biologics Price Competition and Innovation Act, and while it called for meaningful suffixes, said that the FDA’s plan will allow for robust pharmacovigilance and allow for targeted regulatory action if needed.

The naming guidance has also been the subject of intense attention at the international level; the International Generic and Biosimilar Medicines Association, which represents industry members associations both in North America and in Europe, Asia, Africa, Australia, South America, and the Middle East, said it disagrees with the use of suffixes to achieve the shared goal of robust pharmacovigilance. According to IGBA’s comment letter, the FDA should take part in the global consensus on product identification in order not to undermine cross-border pharmacovigilance activities, including the implementation of the Identification of Medicinal Products standards that have been developed to ensure interoperability across global regulatory communities.

IGBA highlighted the fact that European pharmacovigilance systems have achieved 96.7% product identification across 10 classes of biologics and biosimilars without the use of suffixes, and it said that a 2-tier naming system creates confusion and is “illogical, inconsistent, and unfounded.”

Furthermore, IGBA took issue with the FDA’s stated concern about the cost of retrospectively assigning suffixes to the names of already approved biologics, writing that “if retrospective application is too complicated and costly to implement, as the 2019 naming guidance update suggests, the suffix-based system must be removed for all biologics, including biosimilar medicines.”