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…
Shanghai Junshi Biosciences Co. Ltd. and Mabwell Bioscience Co. Ltd. announced that the jointly developed adalimumab biosimilar injection (Junmaikang ®) was officially approved by the Chinese National Medical Products Administration (NMPA) for marketing authorization (drug approval number: Sinopharm S20220008). Junmaikang® is used for the treatment of rheumatoid arthritis, ankylosing spondylitis,…
On Monday, Biocon Biologics Limited (Biocon) announced that it will acquire Viatris’ rights in biosimilars assets for up to $3.3 billion. Viatris and Biocon previously partnered to bring SEMGLEE to market in the U.S. SEMGLEE (insulin glargine-yfgn) injection launched last year in the U.S. as the first-ever interchangeable biosimilar approved…
Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes new data supporting interchangeability between ATV02 and Humira. According to Alvotech’s press release, the data are from a…
Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie’s Humira to Samsung Bioepsis’s biosimilar adalimumab product, SB5, were presented last week at the European Crohn’s and Colitis Organization’s annual meeting. SB5 received EU marketing authorization in August 2017. According to the presentation, the…