FDA Releases Updated Draft Guidances On Naming Biosimilars, Reference Products

By Alexa Josaphouitch, /alert Contributor
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The FDA recently released new draft guidance regarding the naming of biological products. Going forward, the FDA intends to designate a proper name that is the combination of the core name and a distinguishing four letter suffix devoid of meaning. FDA does not intend to modify names of biological products that have already been approved.

As stated in FDA Commissioner Scott Gottlieb’s press release, the FDA’s aim of the naming convention is 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.”


DNA strand. Source: Getty

FDA’s previous guidance in January 2017 was to use a distinguishing suffix to the proper names of biological products, which include biosimilars and originator products. The core objectives of the naming convention are pharmacovigilance and safe use. The name of the product should allow for accurate identification by practitioners and patients as well as minimize inadvertent substitution of biological products. Routine use of the designated suffixes would aid in the ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices.

The proper names of the 17 approved biosimilars have four-letter suffixes as do the 27 originator biological projects. Only those products licensed prior to the implementation of the policy will lack a suffix. To change these names would be costly and if these costs were passed to the patient, it would hinder the goal of biosimilars being an accessible and affordable option, the FDA claims.

There were two approaches to the format of the suffix: a unique suffix that distinguishes an interchangeable product from other products sharing the same core name, or a suffix shared with the reference product. FDA is suggesting that a unique suffix would allow manufacturer-specific pharmacovigilance as it provides a way to track which biological product is dispensed to patients when other means to track this is not readily accessible or available. It would also avoid changes to the name of a biological product that is licensed as a biosimilar product and later determined to be an interchangeable product.

Many stakeholders disagree with this guidance as it could hinder the approval process and the adoption of biosimilar products.

Christine Simmon, Executive Director of Biosimilars Council said in a statement, “AAM is reviewing the FDA’s new draft guidance on biosimilar naming requirements and will submit comments to the docket. FDA’s current requirement of suffixes presents a significant, artificial barrier to biosimilars that is misaligned with the agency’s own Biosimilars Action Plan and the Trump administration’s commitment to lowering drug prices for America’s patients.”

The Biosimilars Forum released the following statement: “Today’s announcement by the FDA is a direct blow to biosimilars uptake in the U.S. The decision abandons the retrospective addition of a suffix to origination biologics, leading to an unsubstantiated notion that strict pharmacovigilance is only essential for biosimilars. This decision will disincentivize biosimilar uptake at a time when the government should be implementing policies that incentivize the use of biosimilars, as they are one solution to help attack rising healthcare costs.

The Biosimilars Forum statement also points out the cost savings aspect of biosimilar since they “are proven to be as safe as and effective as the reference product, and could save the U.S. 54 billion dollars in healthcare costs over the next decade. To realize this saving it will require strong policies to create a more competitive marketplace leading to increased uptake of these lower cost, life-saving treatments.”

Sarfaraz K. Niazi, MD, adjunct professor at the University of Illinois, founder of Pharmaceutical Scientist, Inc, also released a citizen petition against the naming guidance. Niazi has been developing biosimilars for over 25 years with regulatory filings across the globe, including with the FDA. His citizen petition states that “the Agency should modify the naming guidance by eliminating the requirement of a suffix to nonproprietary name, add a condition to use a brand name for biosimilars and continue to use an NDC on the label.”

Niazi also took issue with FDA’s definition of biosimilarity as “no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” He wrote, “The Agency should modify the use of ‘no clinically meaningful difference,’ to ‘clinically similar,’  to avoid this double-negative statement to be misconstrued and misinterpreted.” The FDA has accepted the petition for review (FDA 2019-P-1236). Niazi’s previous citizen petition (FDA-2018-P-1876-001) resulted in the withdrawal of a pivotal FDA guidance on statistical testing of biosimilars.

Although the current guidance is still in the draft phase, the FDA is aiming for the naming procedure of biological products to be finalized by March 2020. FDA is open to further comments and feedback for the next 30-60 days.