Left Hand/Right Hand: Does the Administration Know that FDA Is Undermining Its Efforts to Lower Patient Drug Costs via Biosimilar Competition?

President Trump, HHS Secretary Alex Azar, and former FDA Commissioner Scott Gottlieb, MD, have all championed biosimilars as critical to the administration’s efforts to lower drug prices and reduce out-of-pocket costs for America’s patients. Indeed, competition from FDA-approved biosimilars for costly medicines that treat many forms of cancer, rheumatoid arthritis, psoriasis, Crohn disease, ulcerative colitis, and other conditions, stand to save the US healthcare system an estimated $54 billion over 10 years. Biosimilars are now coming to market at an average 47% discount off the reference biologic’s list price.¹ Americans seem poised to reap the same benefits Europeans have enjoyed for over a decade: less costly versions of critically needed treatments for serious diseases.

Except the FDA is committing a serious policy misstep that puts this progress at risk by adding a random, meaningless 4-letter suffix to the names of biosimilar products that are approved to treat the same diseases as their reference biologics. While FDA’s Janet Woodcock, MD, recently called concerns regarding suffixes “detached from reality,” this requirement for biosimilars serves only to confuse patients, prescribers, pharmacists, and other healthcare professionals while simultaneously undermining confidence in the safety and efficacy of these products.

There is a growing global consensus that the naming of branded biologics and their competitive biosimilar alternatives should not differ. Worldwide, biologics, and biosimilars are identified by their brand name and International Nonproprietary Name (INN), a unique name designated by the World Health Organization that identifies the active ingredient in a drug, and they share the same INN as the brand-name reference biologic product. Most recently, both Health Canada and Australia decided to adopt a naming policy that identifies all biologic medicines, including biosimilars, by their unique brand name and nonproprietary name without the addition of a product-specific suffix.

The suffix matters because it acts as a significant, artificial barrier to biosimilars that is misaligned with the agency’s and administration’s commitment to lowering drug prices for America’s patients. Unfortunately, the FDA recently “doubled-down” on their requirement to add random, meaningless suffixes to biosimilars and proposed to remove the requirement for their already approved brand biologic counterparts. Particularly troubling is the FDA’s proposal to add suffixes to interchangeable biologics that the agency has deemed safe to automatically substitute at the pharmacy counter. Such contradictory regulations will clearly confuse pharmacists, patients, and providers, and will cause apprehension about biosimilars.

So why is FDA making policy that undermines the president’s efforts to reduce drug costs and set up the United States as a global outlier? The agency maintains that the requirement is necessary to ensure adequate pharmacovigilance in case of an adverse event with these products. However, existing naming conventions for the thousands of FDA-approved medicines are already sufficient to address any safety concerns, as evidenced by the fact that FDA will not retroactively apply the suffix requirement to marketed brand biologics.

Numerous stakeholders, including the Federal Trade Commission, pharmacists, health plans, manufacturers, and consumer groups, agree that a suffix confers no safety benefit but rather leads to patient and prescriber confusion, increases the possibility of medication errors, and effectively separates the biosimilar from existing safety information about the originator.

Meanwhile, the European Union, which has approved the most biosimilar medicines worldwide and has more than 700 million patient days of safe and efficacious biosimilar use, has not identified any difference in the “nature, severity or frequency of adverse effects between biosimilars and their reference medicine” during the last 10 years. Further, the results of a European Medicines Agency study showed that 96.7% overall product identification was achieved across 10 classes of biologic products, including biosimilars, sharing the same International INN.

The reality is this: there is simply no compelling reason to add additional identifiers for biosimilar drugs. A recent report found that, according to FDA's own Adverse Event Reporting System, 99% of biosimilars’ adverse events were reported using the products brand name, directly contradicting FDA’s stated purpose for the suffix.

It is telling that the biggest proponents of adding random, meaningless suffixes to biosimilars are manufacturers of brand biologics: the stakeholders who benefit most from the confusion caused by differentiated names for their competition. Moving forward, we urge the FDA to reconsider its guidance on suffix requirements and “walk the talk” on fostering biosimilar competition to improve access to affordable treatments for America’s patients.

Reference

1. Analysis of IQVIA wholesale acquisition cost data for January 2019.