Samsung Bioepis’ PYZCHIVA On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA…
Samsung Bioepis’ PYZCHIVA On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA…
In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron. Regeneron had limited…
FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024….
In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22,…
On May 28, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Celltrion related to its denosumab biosimilar of Amgen’s PROLIA and XGEVA….
On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar….
As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and…
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation…
On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the…
On April 23, 2024, Alvotech announced “positive topline results from a confirmatory clinical study for AVT05,” Alvotech’s proposed golimumab biosimilar to Janssen Biotech,…