The Federal Trade Commission has asked the Food and Drug Administration to reconsider its proposed guidance for naming biosimilar drugs, arguing that it could cause confusion among providers and patients over the safety and efficacy of these products.
In August, the FDA proposed adding a four-letter suffix to the nonproprietary names shared with brand-name biologics. The FDA naming system followed the model proposed in 2014 by the World Health Organization, which oversees the International Non-Proprietary Names system (INN). The WHO recommended that biosimilars receive the same nonproprietary name but with a four-letter code at the end.
Those who oppose similar naming, including brand-name drugmakers and some physician groups, say giving biosimilars the same INN designation as the branded biologic products could lead to confusion among physicians and patients over which drugs they can trust to be safe and effective. They also say using the same name could make it harder to track adverse reactions.
But in its comments (PDF) submitted Oct. 27, the FTC said the FDA's draft guidance on naming “could result in physicians incorrectly believing that biosimilars' drug substances differ in clinically meaningful ways from their reference biologics' drug substances.” The FTC suggested the FDA's proposal would hinder competition that was intended to lower prices on biologic medications, which make up many of the most expensive types of drugs on the market.
The FTC suggested that the FDA track the drugs by their brand or trade name instead of employing a new nonproprietary naming system for biosimilars and biologics. That approach, it said, would help to more accurately track drugs in the post-market and reduce the chance of mistakes being made when entering information, such as putting the wrong suffix down for a particular drug
Biosimilars copy the effects of a biologic drug but are different from generics in that they are not identical in their composition or production to the original product.
The FTC argued having different suffixes could cause providers to misperceive biosimilars as having a “clinically meaningful difference” from a biologic reference product.
“FTC staff is concerned that FDA's proposal for distinct suffixes on biologics' nonproprietary names could reduce biosimilar competition,” the agency said. “It is unclear to what extent physician misperception resulting from FDA's proposal might threaten the full potential benefits that healthcare consumers could recognize from biosimilar competition. However, given the availability of alternative approaches that also appear likely to achieve the FDA's objectives for this naming convention without introducing the potential harm to competition discussed herein, FTC staff respectfully suggests that the FDA reconsider its approach as set forth in the Draft Naming Guidance.”
Whether or not to name biosimilars with the same nonproprietary name as an original biologic has been a contentious issue for several years. Some experts predict that how biosimilar products are labeled will be a key factor determining the success of the biosimilars industry, which is seen as important to the future of controlling rising drug costs. The naming issue will be particularly important when some biosimilar products eventually receive FDA approval for interchangeability, meaning that pharmacists can switch from a branded biologic to a cheaper biosimilar without physician consent, as they do with chemical generic drugs.
Some have estimated the market for such drugs could reach $60 billion by 2020 as the patent protections on a number of biologic medications are set to expire over the next several years.
Proponents feel biosimilars could help to slow the rising costs of biologic medications. The FTC estimated the price of such drugs were on average 22 times higher than traditional medications, with the average cost of biologics rising at a rate between 10% and 15% a year.
Stakeholders including insurers, pharmacy benefit managers, and the Generic Pharmaceutical Association have come out against the FDA's plan for naming. They prefer designating biosimilars with the same nonproprietary name as the original biologic. They say the FDA's plan would discourage competition and the potential for cost savings.
“Adding the suffix attached by a hyphen ultimately does change the name of the substance, and we do not agree with that,” David Gaugh, vice president of regulatory sciences for the Generic Pharmaceutical Association. “There's still a lot of opportunity for the FDA to move in the direction that many of us have asked for and that's to not change the INN.”
Supporters of the FDA guidance, which include brand-name drugmakers and a number of physician groups, say more studies are needed on the long-term clinical effects of biosimilars before they are given the same designation as biologic medications that have a long track record.
“The best way to encourage competition in the biologic market is transparency via naming and labeling that demonstrates what the biosimilars are and what they're not,” said Emily Alexander, director of U.S. regulatory affairs for biopharmaceutical firm AbbVie. “A nonproprietary name that is similar but distinguishable to the reference product will signal to physicians that these products are in fact similar but not identical versions of the reference product.”