Proposed FDA Rule on Biosimilars Suffix Sparks Industry Concerns

Published May 28, 2019

“The suffix matters because it acts as a significant, artificial barrier to biosimilars that is misaligned with the agency’s and the administration’s commitment to lowering drug prices for America’s patients,” Christine Simmon, executive director of the Biosimilars Council and vice president at the Association for Accessible Medicines (AAM), wrote in an article posted on the Center for Biosimilars website. 

The FDA published the revised guidelines, titled “Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability” in March, opening up a 60-day comment period to end May 7. The guidance calls for adding the suffix to the names of all biosimilars regardless of whether they’ve been approved to treat the same disease as their biologic counterparts. 

The proposal would have a critical effect on the success of biosimilars, says AMM, because it would affect what happens at the pharmacy counter.

“A product may be on the market and not automatically substitutable during the pharmacy dispensing process, and then later gain the inter-changeable designation allowing for automatic substitution,” stated a letter to FDA signed by 29 “stakeholder” groups like the American Association of Retired Persons. “These types of scenarios could introduce unnecessary barriers and will require re-education of healthcare professionals for specific products.”

Doing No Harm?

In a March 7 statement, the FDA’s then-Commissioner Scott Gottlieb said although the agency is aware of the biosimilar industry’s concerns, he did not think that the rule would harm the industry.

“We strongly believe in the ability of biosimilars to promote competition, lower prices and foster greater access,” Gottlieb wrote in the statement. “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.”

Letters by AAM, industry stakeholders and seven tax and consumer groups to Acting FDA Commissioner Norman Sharpless urges the agency to change course. The letter says the suffix will cause confusion for patients, pharmacies, and providers without providing any added safety benefit, and FDA approval in and of itself recognizes there is “no clinically meaningful difference” between the drugs.

The tax and consumer groups wrote the suffix policy deviates from the globally recognized International Nonproprietary Name (INN) system. Japan and the United States are the only countries that require biosimilars to carry the suffix. In the European Union, where the INN’s are the same for biologics and biosimilars, consumers have experienced double-digit price decreases, the letter states.

High-Cost Originals

Biologic drugs are therapeutic products derived from living cells and treat a variety of common illnesses such as rheumatoid arthritis, Crohn’s Disease, diabetes, cancer, and eye disease.  Biologics are, however, some of the costliest drugs on the market.  According to the consumer and taxpayer advocacy groups, biologics represent nearly all net spending growth on prescription drugs since 2014.

Biosimilar drugs are the generic equivalent of these biological medicines and were first approved by the FDA in 2015. According to AAM, biologics and biosimilars now account for 46.5 percent of total spending on medicines though comprising only 2 percent of all prescriptions. AAM reports biosimilars have on average a 47 percent lower list price than their brand-name counterparts.

Unpredictable Effects

The disagreement between the biosimilar trade industry and the FDA is a matter of drug industry economics, says David Hyman, a law professor at the Georgetown Law Center, adjunct scholar at the Cato Institute, and coauthor of Overcharged: Why Americans Pay Too Much for Health Care.

“Nobody welcomes low-cost competition,” said Hyman. “We don’t know enough to know what impact this will have. We also don’t know if it will cause consumer confusion. Either biosimilars are identical or similar, and how similar, if similar is enough, [are they] that we would want to disclose it to people.”

Hyman says when pharmacies began substituting generic drugs for brand name versions, the law didn’t require a special naming convention for generics.

“Pharmacists will automatically swap generics for brand names, but I’m not sure how this would work for biosimilars,” said Hyman. “Branded companies don’t advertise drugs when they go generic.”

The FDA’s new draft rule on the proposed suffixes is expected by May 31.

AnneMarie Schieber([email protected])is managing editor of Health Care News.

Internet Info:

Letter to FDA by the Association for Accessible Medicines and the Biosimilars Council, “Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability, May 7, 2019

Letter to FDA by taxpayer and consumer groups on newly released guidelines on biosimilar naming, May 2, 2019:

Letter to FDA by stakeholder groups on newly released guidelines on biosimilar naming, May 7, 2019,