Alvotech Holdings S.A. (“Alvotech”) announced today that it has resolved all intellectual property disputes with AbbVie in Europe related to Alvotech’s AVT02 (adalimumab) biosimilar candidate. This announcement follows Alvotech’s announcement last month that the company had settled its pending disputes related to AVT02 with AbbVie in the U.S., and states…
Lannett Company Announces Initiation of Pivotal Clinical Trial for Biosimilar Insulin Glargine On March 29, 022, Lannett Company (NYSE: LCI) announced the initiation of its pivotal clinical trial of biosimilar insulin glargine, which is being co-developed with Lannett’s strategic alliance partners within the HEC Group of companies. Lannett reported that…
On March 15, 2022, the Patent Trial and Appeal Board (PTAB) denied institution of post-grant review (PGR) proceedings initiated by Celltrion Inc. concerning Regeneron Pharmaceutical’s U.S. Patent No. 10,857,231 (the ’231 Patent) after Regeneron disclaimed the patent. The ’231 patent has claims directed to formulations of aflibercept, the active ingredient…
On March 30, 2022, Medytox filed a complaint with the ITC requesting that the ITC block imports of Hugel’s follow-on biologic Letybo® (LetibotulinumtoxinA) product. The complaint alleges that Hugel expects to obtain approval and launch its product in the U.S. in 2022. The complaint alleges that “Hugel misappropriated Medytox’s trade…
On March 24, 2022, Celltrion Healthcare announced that it had won a bid to the Brazilian Federal Government to supply a biosimilar version of Remsima® (infliximab), along with bids to 12 Brazilian states. According to the company, infliximab will be the third biosmilar product that Celltrion is to supply to…
On March 22, British Columbia’s Ministry of Health announced that three new enoxaparin biosimilars, Valero Pharmaceuticals’ REDESCA, Juno Pharmaceuticals’ , and Sandoz’s INCLUNOX, would be covered by PharmaCare, the province’s public health plan. Enoxaparin is a blood thinner that is used for the prevention and treatment of blood clot disorders. …
The U.S. Attorney’s Office for the Northern District of California has announced that Racho Jordanov, a co-founder and former Chief Executive Officer of JHL Biotech, and Rose Lin, a co-founder and former Chief Operating Officer of JHL, plead guilty to conspiracy to commit theft of trade secrets and wire fraud, and…
Last week, OcyonBio announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions, Inc. in Puerto Rico. According to the press release “OcyonBio is creating an advanced therapy contract development, manufacturing organization (CDMO) that provides pre-clinical through commercial manufacturing, including process development, plasmid DNA, viral…
On March 19, 2022, the parties in the Amgen Inc. v. Hospira Inc. (D. Del., No. 20-201) NEULASTA®/pegfilgrastim litigation submitted a stipulation to dismiss all claims and counterclaims in the litigation with prejudice. The Court (Judge Connolly) entered the order of dismissal on Monday. The case has been pending since February…
Tomorrow, March, 22, 2022, the FDA will host a public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in in the Biosimilar User Fee Act.” As part of the Biosimilar User Fee Act (BsUFA), the FDA contracted with independent third parties to assess the extent…