When does biological data exclusivity for keytruda expire in the us?

When does Keytruda’s “biological data exclusivity” expire in the U.S.?

Keytruda’s biological data exclusivity expires on March 6, 2024 in the U.S. [1].

What “biological data exclusivity” means for biosimilars

This exclusivity blocks FDA approval of a biosimilar or interchangeable product that relies on the reference product’s unpublished biological test data for a period set by the Biologics Price Competition and Innovation Act (BPCIA). Once the exclusivity expires, FDA can accept applications that reference the original product’s data, though other requirements (like patent status) can still affect market entry.

Does patent protection still matter after data exclusivity ends?

Yes. Even after biological data exclusivity expires, patents covering Keytruda (and its use) may still prevent launch of biosimilars or interchangeable products until those patent rights expire or are resolved through litigation or other mechanisms. Data exclusivity and patent protection are separate barriers.

Source

[1] https://www.drugpatentwatch.com/p/keytruda-biologics-data-exclusivity/