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Showing posts from June, 2020

Why a biologic was still in the Orange Book months after all others were transitioned to BLAs

The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) contained a provision that would change the NDAs for biological products to BLAs after the tenth anniversary of the BPCIA’s enactment. [See section 7002(e)(4) of the BPCIA]. As I discussed in my last blog posting, the FDA deleted, on schedule, all of the biologic products that were listed in the Electronic Orange Book (“EOB”). Except for Sanofi’s two insulin glargine products, LANTUS and LANTUS SOLOSTAR. I sent a message to the Orange Book Staff about their retention of the Sanofi products in the EOB, and they responded by referring me to legislation called the Further Consolidated Appropriations Act, 2020 (“FCAA”) that was passed by Congress just before their holiday recess on December 20, 2019. Three pages of the 715 pages of the FCAA, pp. 594-596 (Sections 605-607) contain amendments to the Public Health Service Act (“PHSA”) and BPCIA provisions that involve biological products.Through a cursory search I found tha…