AAM and the Biosimilars Council Oppose FDA Update to Biosimilar Naming

Wednesday May 8, 2019

WASHINGTON, DC (May 8, 2019) – In comments submitted yesterday to the Food and Drug Administration (FDA), the Association for Accessible Medicines (AAM) and its Biosimilars Council urged the FDA to reverse course on its current proposal for the naming of biological products, and rescind the suffix-based naming policy that acts as a barrier to biosimilars access for America’s patients.

“The Agency’s updated guidance on “Nonproprietary Naming of Biological Products” is misaligned with its own Biosimilars Action Plan and undermines the Administration’s commitment to lowering drug prices for America’s patients,” said Christine Simmon, Executive Director of the Biosimilars Council and Senior Vice President of Policy & Strategic Alliances at AAM. “This kind of misguided policymaking delays and derails the development of biosimilars, and is as much of an obstacle for patient access to biosimilars as patent thickets, rebate traps, misinformation campaigns and other anticompetitive tactics used by some brand biologic manufacturers.”

A letter to FDA Commissioner Ned Sharpless signed by 28 patient, consumer, taxpayer, employer, pharmacy, provider, health plan and other groups bolstered AAM and the Council’s position noting,  “The FDA’s current system of requiring random suffixes for biosimilars and not for their approved reference products fails to confer any safety benefits and ultimately leads to confusion for patients, prescribers, pharmacists and other healthcare providers. Moreover, this approach creates the perception that there are meaningful differences between FDA-approved biologics and biosimilars, when, in fact, agency approval explicitly indicates they have ‘no clinically meaningful differences’.”

The diverse list of signatories includes AARP, AHIP, APhA, Campaign for Sustainable Rx Pricing (CSRxP), CVS Health, National Business Group on Health, Prevent Cancer Foundation and Rite Aid, among many  others.


Rachel Schwartz


About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), 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.

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