Earlier this week, Alvotech announced that it has completed enrollment of its Phase III study of AVT02, its proposed biosimilar of Humira® (adalimumab). The study has enrolled 407 patients…
Earlier this week, Alvotech announced that it has completed enrollment of its Phase III study of AVT02, its proposed biosimilar of Humira® (adalimumab). The study has enrolled 407 patients…
As we previously reported, on July 10, 2019, Genentech filed motions for a temporary restraining order and preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to…
Last night, Genentech filed a motion for a temporary restraining order and a motion for a preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to Amgen’s…
Below are some highlights of recent news in biosimilar and follow-on biologic development: Prestige BioPharma On July 2, Prestige BioPharma (Prestige) licensed the rights to Tuznue, its…
Today, June 28, 2019, the FDA approved Pfizer’s aBLA for ZIRABEV (bevacizumab-bvzr), a biosimilar of Genentech’s AVASTIN. According to its approved package insert, ZIRABEV is indicated for…
U.S.-based AbbVie, Inc. has reached a deal to acquire Irish pharmaceutical company Allergan PLC for about $63 billion, according to an AbbVie press release from Tuesday. The “definitive…
On June 7, 2019, Amgen filed a petition for rehearing en banc of the Federal Circuit’s recent affirmance of summary judgment of non-infringement in favor of Sandoz in the BPCIA…
Today, June 13, 2019, the U.S. FDA approved Amgen’s aBLA for KANJINTI (trastuzumab-anns), a biosimilar of Genentech’s HERCEPTIN. According to its approved package insert, KANJINTI, like its…
On June 8, 2019, Fresenius Kabi filed a petition for inter partes review challenging the validity of U.S. Patent No. 9,643,997, entitled “Capture purification processes for proteins expressed…
Today, AbbVie and Boehringer Ingelheim (“BI”) announced that they reached a resolution of all intellectual property-related litigation concerning BI’s proposed biosimilar Cyltezo®…