The U.S. FDA recently approved Genentech’s Phesgo™ for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy. Phesgo™ is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection. Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab…
We have previously reported on the class action suit against AbbVie alleging misconduct and antitrust violations in connection with AbbVie’s assertion of its patents against biosimilar manufacturers to prevent the sale of biosimilar versions of Humira® (adalimumab) in the United States. On June 8, 2020, in a Memorandum and Opinion…
The Korean Herald reported today that Celltrion has applied for the European Medicine Agency’s approval of CT-P17, a Humira (adaliumumab) biosimilar. According to the Korean Herald, Celltrion “expects to introduce CT-P17 to the European market in about a year’s time, which is how long the EMA typically takes to review.” …
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 with moderate-to-severe chronic plaque psoriasis and will occur across approximately 30 sites in Europe “to compare AVT02 and Humira® in terms…
On March 18, 2019, UFCW Local 1500 Welfare Fund, a New-York based grocery union, filed a putative class-action lawsuit against AbbVie and seven adalimumab biosimilar manufacturers alleging misconduct and antitrust violations in connection with AbbVie’s assertion of patents to prevent the sale of biosimilar versions of Humira® in the United States….
Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira® (adalimumab). According to the press releases, the deal authorizes Momenta to launch its adalimumab biosimilar, M923, in the United States…
Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. According to…
Abbvie and Fresenius Kabi have announced today that they entered into a worldwide settlement and licensing arrangement resolving all intellectual property-related litigation concerning Fresenius’s MSB11022, a biosimilar candidate of AbbVie’s HUMIRA (adalimumab). According to the press releases, under the terms of the royalty-bearing settlement and license agreements, AbbVie has granted…
In a complaint filed yesterday, the State of California sued AbbVie, Inc. based on an alleged kickback scheme in connection with AbbVie’s Humira® (adalimumab). The complaint alleges that AbbVie violated the Insurance Frauds Prevention Act (“IFPA”) by providing kickbacks to health providers throughout California. Specifically, AbbVie allegedly indirectly paid healthcare…
On September 12, 2018, Boehringer Ingelheim announced positive results from a Phase III clinical trial for its approved adalimumab biosimilar, Cyltezo®. The clinical trial compared the efficacy, safety and immunogenicity of Cyltezo® and Humira® in patients with moderate-to-severe chronic plaque psoriasis. According to Boehringer Ingelheim, the study confirmed equivalence of Cyltezo®…