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…
On March 14, 2022, Prestige BioPharma Ltd., a Singapore-based biopharmaceutical company, announced positive safety and efficacy results in a Phase III study (“TROIKA”) for HD201, a biosimilar to HERCEPTIN (trastuzumab). The results of the TROIKA study were published in JAMA Oncology on March 3, 2022. In the double-blind trial, researchers…
On March 7, 2022, the US Food and Drug Administration (FDA) issued a Funding Opportunity Announcement (FOA) to commit up to $5 million in fiscal year 2022 toward several research proposals. Specifically, the FDA anticipates awarding as many as five proposals up to $1 million in funding. This FOA arises…
Big Molecule Watch honors Women’s History Month by recognizing the women who have contributed to the advancement of biologics and biosimilars. We highlight one such individual, Rosalyn Yalow, who received a Nobel Prize for Physiology or Medicine in 1977 for her work on radioimmunoassay. Dr. Yalow, together with her research…
On March 3, 2022, the PTAB instituted another inter partes review of U.S. Patent Nos. 8,580,264 (“the ’264 patent”), owned by Chugai and Roche. Fresenius filed a petition for inter partes review of the ‘264 patent, challenging claims 4, 5, and 12, directed to methods of treating rheumatoid arthritis by…
Alvotech Holdings S.A. (“Alvotech”) has announced that they have settled all pending disputes between AbbVie and Alvotech related to AVT02 (100mg/mL), Alvotech’s high-concentration, citrate-free biosimilar candidate for Humira® (adalimumab). The announcement states that under the settlement agreement, Alvotech has non-exclusive rights to market AVT02 in the United States starting July…
Amneal Pharmaceuticals and Kashiv Biosciences have announced that their RELEUKO (filgrastim-ayow) biosimilar recently received FDA approval, making it the third filgrastim biosimilar approved for the United States, as well as the FDA’s first biosimilar approval this year. RELEUKO references Neupogen®, and is expected to launch in the third quarter of…