Biosimilars Council Joins Pharmacies, Payers and Others in Message to FDA & HHS: Require Same Names for Biologics and Biosimilars to Ensure Patient Safety
Contact: Steve Arnoff 202.249.7113
WASHINGTON, DC (June 30, 2015) — The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), strongly urges the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to avoid any departure from the currently accepted international nonproprietary naming (INN) system. In a letter sent today to HHS and FDA, the Biosimilars Council joined a diverse group of healthcare stakeholders to raise shared concerns that adopting distinguishable names for biosimilars and biologics would erect barriers to patient access to new, more affordable medicines and could jeopardize their safety.
“Organizations representing the nation’s pharmacies, pharmacists, insurers, state employee retirement systems, taxpayers, and others agree that biologics and biosimilars should share the same name in order to ensure patient safety and avoid confusion among providers and dispensers,” said Ralph G. Neas, President and CEO, GPhA.
The letter states:
“We share the FDA's deep commitment to patient safety, and as such, we believe that biologics and biosimilars should be required to have the same International Nonproprietary Name (INN). Requiring different INNs for biologics and biosimilars could lead to patient and prescriber confusion, increasing the possibility of medication errors, and would also effectively separate the biosimilar from existing safety information about the underlying molecule.”
Further, these groups believe that the current mechanisms in place (e.g., NDC code, lot number, brand name, manufacturer, etc.) are more than sufficient to allow for the tracking of important safety information related to new biosimilar products:
“We are concerned that any unnecessary changes may interfere with current pharmacy safety alert systems used by both retail and community pharmacists. In addition, because 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, there is no compelling evidence that biosimilars should be handled differently.”
The letter also notes dispensing complications that could arise, resulting in “massive confusion among pharmacists, payers, and PBMs” that could “inhibit patient access to these lifesaving medicines.”
“The Biosimilars Council welcomes the opportunity to work with FDA and others to ensure that the biosimilar market in the United States optimizes patient access to safe, effective and more affordable alternatives to brand-name biologics,” said Neas.
The letter is available here. The full list of signatories includes:
Academy of Managed Care Pharmacy (AMCP)
American Pharmacists Association (APhA)
America’s Health Insurance Plans (AHIP)
The Biosimilars Council
California Public Employees Retirement System (CalPERS)
Council for Citizens Against Government Waste
Healthcare Supply Chain Association (HSCA)
National Association of Chain Drug Stores (NACDS)
National Coalition on Health Care (NCHC)
Ohio Public Employees Retirement System (OPERS)
Pharmaceutical Care Management Association (PCMA)
Premier healthcare alliance
Public Sector Health Care Roundtable
UAW Retiree Medical Benefits Trust
About the Biosimilars Council
The Biosimilars Council works to ensure a positive regulatory, reimbursement, political and policy environment for patient access to biosimilar medicines, and will educate the public and patients about the safety and effectiveness of biosimilars. Areas of focus will include education, access, the nascent regulatory environment, reimbursement and legal affairs. Additional 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 www.gphaonline.org. Follow us on twitter: @gpha.