In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars. Under the BPCIA, approved NDAs for biological products will be “deemed to be a license” as if approved under BLAs as of March 23, 2020 (BPCIA § 7002(e)(4)). Until that date, anyone seeking approval for a generic or follow-on version of biological product approved under an NDA would file a 505 (b)(2) NDA, not a BLA. The FDA interpreted the language of the BPCIA to mean that any application that remains pending on the March 23, 2020 transition date that references a product previously approved under an NDA and deemed approved under a BLA would need to refile their application on or after the transition. In section 607 of the FCAA, Congress allows the FDA to continue reviewing applications for biological products that were filed before March 23, 2019 and remain pending as of March 23, 2020. That means that the 505 (b)(2) NDA submitted by Mylan for a follow-on insulin glargine product referencing LANTUS, should it still be pending on March 23, 2020, can continue to be reviewed for approval as an NDA by the FDA, without having to be refiled as a BLA.
In the FCAA, Congress also adopted another change to the “deemed to be a license” provision of the BPCIA by modifying the BPCIA’s definition of “biological product.” Section 605 of FCAA amends the definition to remove the “any chemically synthesized polypeptide” exception to proteins. As a result, three synthetic peptide products were added to the FDA’s list of approved NDAs for biological products that will be deemed to be BLAs on March 23, 2020. The synthetic peptide products added to the list are: Acthrel (corticorelin ovine triflutate), Egrifta (tesamorelin), and Adlyxin (lixisenatide).
Finally, section 610 of the FCAA mirrors provisions from the CREATES Act and seeks to mitigate concerns over reference product manufacturers refusing to provide samples to generic/biosimilar developers. Under certain circumstances, section 610 creates a new private cause of action that generic/biosimilar developers may bring against reference product manufacturers. Companies seeking to develop generic or biosimilar products may file a civil suit against reference product license holders in a federal district court for failure to supply sufficient quantities of a covered product on commercially reasonable, market-based terms. Previously, generic/biosimilar product developers were limited to filing antitrust actions alleging anti-competitive behavior. Section 610 of the FCAA may provide an additional remedy for generic and biosimilar product developers that are unable to obtain samples of reference products.
The post Congress Adopts Biosimilar Related Provisions in the 2020 Appropriations Act appeared first on Big Molecule Watch.