The FDA has released a draft guidance, Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts, for public comment (posted 31 July 2026). Comments may be submitted at any time, but should be submitted by 2 October 2026 to be considered before the Agency begins work on the final guidance.
Issued jointly by CDER and CBER, the draft guidance is intended to help applicants develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. It expands on and clarifies the Agency's expectations previously described in Q.I.4 of "Questions and Answers on Biosimilar Development and the BPCI Act" and in "Considerations in Demonstrating Interchangeability With a Reference Product." It touches topics across several communities:
Please review the draft guidance and respond by close of business on Monday, August 10:
Here is the link:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biosimilar-and-interchangeable-biosimilar-products-considerations-container-closure-systems-and
------------------------------
Subathra Ramamoorthy
Associate Principal Scientist
Veranova
Westford MA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------