Developers Call FDA Guidance on Suffixes a "Direct Blow" to Biosimilars

After the FDA published updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars, biosimilar developers were quick to voice their concerns. According to industry, the FDA’s decision to require 4-letter, nonmeaningful suffixes for biosimilars, interchangeable biosimilars, and new biologics—but not already approved biologics—could seriously hinder biosimilar uptake.

Christine Simmon, executive director of the Biosimilars Council, a division of the Association for Accessible Medicines (AAM) said in a statement that, while AAM is still reviewing the FDA’s updated draft guidance and plans to submit comments on the federal docket, “FDA’s current requirement of suffixes presents a significant, artificial barrier to biosimilars that is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The Biosimilars Forum told The Center for Biosimilars^® in an email that it considers the updated draft guidance “a direct blow to biosimilars uptake” in the United States. According to the forum, the fact that the guidance reverses course on the agency’s plan to retrospectively add 4-letter suffixes to already approved biologics (such as the innovator biologics on which biosimilars are referenced), will lead to a misconception that strict pharmacovigilance applies only to biosimilars, not to all biologics.

“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,” wrote the forum.

According to Chad Landmon, JD, chair of the intellectual property and FDA practice groups at Axinn, wrote in an email to The Center for Biosimilars^® that biosimilar developers are worried that the standard suffix may affect reimbursement if it suggests inferiority of biosimilars to their references, among other concerns. “This is particularly concerning to the biosimilar companies for products that FDA may eventually deem interchangeable given that such a designation means that there will be no clinical difference between the interchangeable and the innovator product,” wrote Landmon.

Concern about the FDA’s policy on suffixes doesn’t stop at the United States’ borders; the International Generic and Biosimilar Medicines Association (IGBA), an umbrella group that counts among its members biosimilar organizations in the United States, Canada, South America, Europe, Asia, Africa, Australia, and the Middle East, has called the US policy a “notable outlier” that diverges from global consensus on biosimilar naming.

According to a statement from IGBA, there are no data that demonstrate that adding non-meaningful suffixes to the names of biosimilars has improved or will improve pharmacovigilance efforts.

IGBA also pointed to a recent study¹ on European pharmacovigilance that found that adequate identifiers were provided for 96.7% of biologics for which adverse drug reactions were reported between 2011 and 2016, all without the use of product-specific suffixes. According to the study’s authors, “fears of poor product identification when switching between products are not justified.”

Reference

1. Vermeer NS, Giezen TJ, Zastavnik S, Wolf-Holz E, Hidalgo-Simon A. Identifiability of biologicals in adverse drug reports received from European clinical practice [published online November 21, 2018]. Clin Pharmacol Ther. doi: 10.1002/cpt.1310.