by April Breyer Menon | Mar 17, 2023
As of February 28, 2023, there were 40 approved biosimilars of 11 reference products in the U.S. market, seven of which were approved in 2022. This is a marked increase over the prior two years, which had seven total approvals due to COVID-19 related approval...
by April Breyer Menon | Mar 17, 2023
*One litigation is counted twice as it related to patents covering both Neupogen and Neulasta. While Lantus patents have been subject to litigation, none of those litigations were under the BPCIA and thus are not included. As of February 28, 2023, there have...
by April Breyer Menon | Mar 17, 2023
Reviewing the BPCIA litigations to date, we found that the number of patents asserted could play a role in the resolution of the litigation. 21 of the 46 (45.7%) BPCIA litigations involved five or fewer patents, 20 (43.5%) involved more than 10 patents, and 16...
by April Breyer Menon | Mar 17, 2023
*Biosimilar-related IPR outcomes by petition and by patent. IPRs that are still pending are not included. Settled / Terminated includes IPRs that were settled or terminated at the Petitioner’s request prior to a final written decision, and include IPRs terminated...
by April Breyer Menon | Mar 17, 2023
*Outcomes of terminated biosimilar-related IPRs by patent. Patents with no claims invalidated include those that were not instituted, as well as those with IPRs that were terminated without a final written decision. Patents with at least some claims invalidated...