FDA's Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Pursuant to a law enacted in late 2020, a reference product sponsor must 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. Over the last year, patent lists for four additional products have become available: Biogen's TYSABRI (natalizumab), Janssen Biotech's STELARA (ustekinumab), Genentech's ACTEMRA (tocilizumab), and Amgen's PROLIA and XGEVA (denosumab).
Biogen's BPCIA case against Sandoz, related to Sandoz's proposed biosimilar of TYSABRI (natalizumab), is pending in the District of Delaware. Janssen's BPCIA case against Amgen, related to Amgen's proposed biosimilar of STELARA (ustekinumab), is also pending in the District of Delaware.
No district court litigation has been initiated yet in relation to biosimilars of Genentech's ACTEMRA (tocilizumab) and Amgen's PROLIA and XGEVA (denosumab). With respect to tocilizumab, the FDA accepted for review Fresenius Kabi's BLA in August 2022 and Biogen's BLA in December 2022. With respect to denosumab, the FDA accepted for review Sandoz's BLA in February 2023.
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