Health Organizations Pen Letter to FDA Encouraging Action on Interchangeability Guidance

Sunday September 2, 2018

Seventeen stakeholder groups representing a variety of healthcare industry’s sent a letter to FDA, urging greater clarity on interchangeability guidance for biosimilars, highlighting hope that such guidance will positively influence the growth of lower cost, safe ,and effective biosimilars.

The guidance discussed, “Considerations in Demonstrating Interchangeability With a Reference Product,” was released in January of 2017 and is awaiting final issue. As the signatories, including the American Hospital Association, CVS Health and Kaiser Permanente, among others write:

We believe finalizing the interchangeability guidance is a crucial part of achieving cost savings in the biological product market. This guidance will give the industry a clear, consistent framework to demonstrate interchangeability, which in turn will encourage manufacturers to invest in research and development of biosimilar products and to seek the designation of interchangeability for their products. We are very hopeful that this guidance will increase access to affordable biological products and strongly urge the FDA to finalize it as soon as possible.

Biosimilars Council@BiosimsCouncil

This week, stakeholders sent a letter to @US_FDA asking for greater clarity on how the administration determines ” — a designation that would increase access & accelerate savings. 

Read the full letter:

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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