In 2021, the FDA’s Purple Book went live, providing a searchable database of licensed biological products, including the patent information provided to biosimilar applicants during the patent dance. Pursuant to a law enacted in late 2020, a reference product sponsor must now provide patent information to FDA for listing in the Purple Book once it has provided a patent list to a biosimilar applicant pursuant to Section 3(A) of the patent dance provisions of the BPCIA. Given that these patent listings are submitted on a going forward basis, as of the end of 2021, the Purple Book database listed patents for only Abbvie’s Humira (adalimumab) and Genentech’s Avastin (bevacizumab) and Lucentis (ranibizumab). In recent weeks, patent lists for two additional products have become available via the Purple Book: Amgen’s Neulasta (pefilgrastim) and Regeneron’s Eyelea (aflibercept).
Blog Big Molecule Watch April 21, 2022