Statement by Dr. Bertrand C. Liang, Chairman, Biosimilars Council, Regarding FDA Proposals on Biosimilars Naming
Contact: Steve Arnoff 202.249.7113
August 27, 2015 -
“The FDA’s proposals today on naming conventions for biosimilars warrant serious scrutiny for their potential to erect barriers to patient access to new, more affordable medicines, and jeopardize their safety.
Because the Biosimilars Council shares the agency’s deep commitment to patient safety, we believe that biologics and biosimilars should be required to have the same International Nonproprietary Name (INN) with no added “FDA-designated suffix.” Adverse events and product recalls for small-molecule and biologic drugs already are successfully identified using the national drug code (NDC code), and lot number and company name, and there is no compelling evidence that biosimilars should be handled differently. There is already a precedent for shared names (e.g., erythropoietins, somatropin, interferon), which has not resulted in any known patient safety issues. Shared INNs without suffixes are also safely and effectively utilized in EU, Canada, Australia, and Japan. Adding a random collection of letters to the product’s nonproprietary name confers no additional safety benefit, and in fact would require the healthcare professional to be armed at all times with a code-breaking reference.
Moreover, the legislative intent of the biosimilars approval pathway included in the Patient Protection and Affordable Care Act was to support the development of less expensive but equally effective alternatives to biologic drugs. Yet, today’s proposals could create an unnecessary barrier to the benefits of FDA-determined interchangeability. Patients, prescribers and dispensers of these drugs need to be able to easily identify which drugs bear a relation to one another in order to maximize the potential savings from the biosimilar approval pathway.
We look forward to working with FDA and other healthcare stakeholders to ensure that names for biologics, biosimilars and interchangeable biosimilars support patient access to safe, effective and more affordable alternatives to brand-name medicines.”
About the Biosimilars Council
The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.