Resources

These resources provide answers around what biosimilars are, why they are important, how they can improve patient access, and how they can save the United States billions of dollars.

If there is something that you want to know and can’t find in the below links, we encourage you to send us an email and ask your question. We will try to get back to you as soon as possible and are always happy to talk about biosimilars.

Council Resources

Statements of Support

CAGW agrees with the comments made by a representative from the Biosimilars Council before the Arthritis Advisory Committee on July 12, 2016 that stated:

“FDA has used comparability, or extrapolation of information, for nearly 20 years. In such cases, clinical data are typically provided to confirm safety and efficacy of one indication and, taking into account the totality of information gained from the comparability exercise. Based on the acceptable outcome of the comparability and clinical evaluations, the data may then be extrapolated to the other indications.”

Council Statements

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AAM & Biosimilars Council Comments Regarding FDA-2018-N-2689
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Biosimilars Council Statement from FDA Public Meeting
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Biosimilars Council Supplemental Comments on the CY 2018 Physician Fee Schedule
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Biosimilars Council Comments on the CY 2018 Physician Fee Schedule
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Biosimilars Council Praises House Passage of the FDA Reauthorization Act of 2017
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Biosimilars Council Statement on SCOTUS Ruling in Amgen v. Sandoz
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AAM & Biosimilars Council Comments on FDA Interchangeability Guidance
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Biosimilars Council Amicus Brief: Amgen v. Sandoz
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Biosimilars Council Comments on the Biosimilar Approval for Adalimumab
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Biosimilar Council Comments Regarding Biosimilar Labeling
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Biosimilars Council Remarks at FDA Arthritis Advisory Committee Meeting
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Biosimilars Council, Pharmacies, Payers, and other letters to FDA re: biosimilar names
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General Resources

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FDA Biosimilars Educational Resources
U.S. FDA
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Biosimilars Council: A Leading Resource on Biosimilars - Journal of the American Pharmacists Association Article
The Growing Role of Biologics and Biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference
Journal of the American Pharmacists Association
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Biosimilars Learning Modules
IGBA
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2017 AAM Generic Drug Access & Savings
Association for Accessible Medicines
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The Biosimilars Toolkit
The Alliance for Health Reform
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FDA Consumer Updates: Biosimilars
U.S. Food & Drug Administration
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A Citizen’s Pathway Gone Astray
New England Journal of Medicine
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Enabling Competition in Pharma Markets
Brookings Institution
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Overview of Biosimilar Products in the US
U.S. Food & Drug Administration
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Naming and Biological Products
U.S. Food & Drug Administration
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Legislation

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Patient Protection and the ACA
U.S. Food & Drug Administration
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