Patents related to Regeneron’s EYLEA (aflibercept) were recently added to the Purple Book. Under the Biological Product Patent Transparency Act, signed into law December 27, 2020 and codified at 42 U.S.C. § 262(k)(9), patents must be submitted to the FDA for listing in the Purple Book during the “Patent Dance” under the BPCIA. Specifically, within thirty (30) days after the reference product sponsor (RPS) has submitted a list of patents that could reasonably be asserted against the biosimilar manufacturer under § 262(l)(3)(A), the RPS must provide the list of patents and their expiry dates to FDA.
Regeneron listed twenty-nine patents in connection with EYLEA, four of which do not expire until 08/18/2040 (U.S. Nos. 11,053,280, 11,104,715, 11,174,283, and 11,186,625). Although there are multiple aflibercept biosimilars currently under development, all have yet to receive FDA approval. Regeneron’s recent Purple Book listing presumably comes as part of a Patent Dance with Viatris (formerly Mylan), which filed an aBLA for its aflibercept biosimilar MYL-1701P in late 2021. At least six other aflibercept biosimilars are in, or have completed, phase 3 clinical trials. These include SB-15 (Samsung Bioepis), ABP 938 (Amgen), FYB203 (Formycon and Bioeq), SOK583A19 (Sandoz), CT-P42 (Celltrion), and OT-702 (Ocumension Theraputics and Shandong Boan Biological Technology).