The Association for Accessible Medicines Urges FDA to Foster Biosimilars Competition, Confidence Under Action Plan

Friday September 21, 2018

Diverse Stakeholders Say Agency Education Efforts Must Address Misinformation Campaigns to Bolster Patient Trust

WASHINGTON, DC (September 21, 2018) — The Association for Accessible Medicines (AAM) today submitted written comments to the Food and Drug Administration (FDA) on the agency’s efforts to facilitate competition for expensive biologic medicines under its Biosimilars Action Plan, focusing on lowering the costs of biosimilars development, balancing innovation and competition, and educating stakeholders to improve confidence in these medicines.

AAM’s submission expands on verbal comments delivered by Executive Director of the Biosimilars Council and Senior Vice President of Policy & Strategic Alliances, AAM, Christine Simmon, during the agency’s Part 15 Public Hearing, “Facilitating Competition and Innovation in the Biological Products Marketplace,” earlier this month. Simmon commented that “getting biosimilars to patients requires more federal policymakers to build on the important steps the FDA already has taken or will take under the Biosimilars Action Plan…As the Administration continues to implement its Blueprint to lower drug prices for America’s patients, FDA is the engine that can drive policymakers to leverage biosimilars opportunities.”

AAM and the Council provided details on several ways FDA can meet its stated goal of facilitating competition and innovation in the biological products marketplace, including: working within the Department of Health and Human Services (HHS) to advance incentives to ensure further market penetration and timely adoption of lower-priced, life-saving biosimilars; accelerating the education of physicians, patients and other key stakeholders regarding the safety and effectiveness of FDA-approved biosimilars; addressing misinformation campaigns designed to deter switching to biosimilars; and advancing biosimilar interchangeability through guidance.

Additional stakeholders recognize the importance of advancing U.S. biosimilars. In a group letter to the FDA, a diverse coalition of 29 stakeholders said, “we recognize and support FDA’s goal to create a robust biosimilars market that offers patients greater choice and access to more affordable therapies.” The group, comprising organizations representing patients, consumers, providers, pharmacists, payers, industry and pharmaceutical supply chain entities, also urged the agency to continue to prioritize education and to take aggressive steps to combat misinformation.”

The letter was signed by leading health care policy and advocacy organizations, including: America’s Health Insurance Plans (AHIP), American College of Physicians, American Pharmacists Association (APhA), CancerCare, Citizens Against Government Waste (CAGW), CVS, Express Scripts, Global Healthy Living Foundation (GHLF), The Heartland Institute, National Association of Chain Drug Stores (NACDS), National Consumers League (NCL) and Pharmaceutical Care Management Association (PCMA).

The full letter can be viewed here.

Media Contact: Rachel Schwartz, [email protected], (202) 249-7147

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 on our about page.

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. Additional information is available at

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