On August 23, 2022, Amgen announced positive top-line results from a phase 3 study of ABP 959, Amgen’s proposed biosimilar to SOLIRIS (eculizumab). Amgen noted that the study was “a…
On August 23, 2022, Amgen announced positive top-line results from a phase 3 study of ABP 959, Amgen’s proposed biosimilar to SOLIRIS (eculizumab). Amgen noted that the study was “a…
We previously reported on Regeneron’s antitrust suit against Amgen in the U.S. District Court for the District of Delaware. Amgen recently filed a motion to dismiss Regeneron’s Complaint and a…
The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars. Here we report on the results of two recently completed studies. On June 30, 2022, a study…
The Seventh Circuit issued this week a long-awaited opinion in the HUMIRA antitrust litigation, UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402. The appeal is from the…
Amgen recently released a preview of its 2022 Trends in Biosimilars Report, which includes an analysis of the trends in US biosimilar launches and approvals; a timeline of biosimilar approvals…
On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen’s RIABNI (rituximab-arrx), a biosimilar to Genentech’s RITUXAN®, in combination with methotrexate…
Genentech filed a complaint yesterday against Tanvex in the U.S. District Court for the Southern District of California, alleging infringement of three patents under the BPCIA based on…
Late last week, Regeneron Pharmaceuticals, Inc. filed an antitrust complaint against Amgen Inc. in the U.S. District Court for the District of Delaware. Regeneron alleges that “Amgen is engaged…
Amgen recently announced preliminary results from a Phase 3 study evaluating the efficacy and safety of ABP 654 compared to STELARA (ustekinumab) in adult patients with moderate to severe plaque…
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…