On December 27, the President signed the Consolidated Appropriations Act, which includes two provisions relevant to biosimilars:
First, Section 322 of Division BB permits but does not require aBLAs to include information to show that the biosimilar’s conditions of use are the same as conditions of use approved for the RLD.
Second, Section 325 of Division BB, “BIOLOGICAL PRODUCT PATENT TRANSPARENCY,” requires FDA within 180 days to create a searchable, electronic list of licensed biologics (including “deemed” biologics under the BPCIA’s transition provision); to update that list monthly thereafter; and to include in it exclusivities and patent information included on (3)(A) lists, which every RPS that sends a (3)(A) list to a biosimilar applicant must share with FDA within 30 days after sending it to the biosimilar applicant. There will be a request for public comment in 2023 regarding what should be added to or deleted from the list.
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