As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation…
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,…
Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy’s Laboratories (“DRL”) and Fresenius Kabi. As we previously reported, Genentech,…
As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation,…
On April 1, 2024, the Federal Circuit released its opinion in Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., affirming the district court’s finding that certain…
Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab. ZYMFENTRA™, approved by the FDA in October 2023,…
Regeneron’s request for multi-district litigation As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a motion seeking to establish…
Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab). Phase 3 studies demonstrated that in patients with chronic spontaneous urticaria, CT-P39…
On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s…