Comments of the Healthcare Supply Chain Association (HSCA) to FDA on Facilitating Competition and Innovation in the Biological Products Marketplace

On behalf of the Healthcare Supply Chain Association (HSCA), thank you for the opportunity to provide comments on the U.S. Food and Drug Administration’s (FDA) “Facilitating Competition and Innovation in the Biological Products Marketplace.”

The ability to safely substitute FDA-approved biosimilars for reference biologics will be critical to realizing the full cost-savings potential of biosimilars and will ensure that patients have timely access to safe, less-costly therapies. HSCA and its member healthcare group purchasing organizations are committed to lowering costs through increased competition and innovation in the healthcare marketplace and have consistently advocated for policies to ensure a pathway to market for biosimilars that prioritizes patient safety and cost savings.

We applaud the FDA for recognizing the value of a competitive and innovative biosimilars marketplace and respectfully offer the following recommendations to promote the swift uptake of biosimilar products:

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