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Insurers, CVS Call on FDA to Finalize Interchangeable Biosimilar Guidance

Posted 23 August 2018 | By Zachary Brennan 

Insurers, CVS Call on FDA to Finalize Interchangeable Biosimilar Guidance

The US Food and Drug Administration (FDA) should finalize guidance on interchangeable biosimilars to increase cost savings, a letter from a group of 17 insurers and other groups, including Kaiser Permanente, Blue Cross Blue Shield and CVS, to FDA Commissioner Scott Gottlieb said on Thursday.

By keeping the current interchangeability guidance in draft form, FDA is creating “significant uncertainty” in the biologics market that could discourage similar levels of substitution for the highest-cost products.
“While the FDA has approved 12 biosimilar products to date, none have been deemed interchangeable, and therefore they cannot be substituted without the intervention of a health care provider,” the groups say.

FDA’s biosimilars lead Leah Christl has said interchangeable biosimilars could be expected within two years, which would mean they may come to market as early as next June. However, biopharma companies have said the finalization of the guidance is not what is keeping them from bringing interchangeable biosimilars to market, as the study requirements are well understood.

Nonetheless, the groups say in their letter that finalizing the 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.”

Letter

Categories: Regulatory News

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