This week, stakeholders sent a letter to @US_FDA asking for greater clarity on how the administration determines #biosimilar “#interchangeability” — a designation that would increase access & accelerate savings. https://www.axios.com/newsletters/axios-vitals-ce297a2d-3b8f-446f-8b5c-7911a5ec41e7.html?chunk=4#story4 …
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.