In finalizing its 2025 Medicare Advantage and Part D rule, the U.S. Centers for Medicare & Medicaid Services (CMS) all but did away with the coverage differences between biosimilars and interchangeables.
South Korean biosimilar-focused Alteogen Inc. said on March 27 that Chung Hye-shin, former chief strategy officer (CSO) and co-founder, sold 1.6 million of Alteogen shares for ₩316.4 billion (US$234.24 million) to foreign institutional investors.
South Korean biosimilar-focused Alteogen Inc. said on March 27 that Chung Hye-shin, former chief strategy officer (CSO) and co-founder, sold 1.6 million of Alteogen shares for ₩316.4 billion (US$234.24 million) to foreign institutional investors.
As investment in Asia biohubs continues into 2024, Merck KGaA’s Milliporesigma is the latest to drop more than €300 million (US$328 million) into a new bioprocessing production center in Daejeon, South Korea.
As investment in Asia biohubs continues into 2024, Merck KGaA’s Milliporesigma is the latest to drop more than €300 million (US$328 million) into a new bioprocessing production center in Daejeon, South Korea. Other big pharmas, including Switzerland’s Novartis AG, Denmark’s Novo Nordisk A/S and China’s Wuxi Biologics (Cayman) Inc., are also making multimillion-dollar investments in the Asia-Pacific region, according to company announcements made in March 2024.
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
The biosimilars revolution continues with the U.S. FDA’s approval of the first denosumab biosimilars: Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) from Sandoz Inc. for treating osteoporosis and to prevent bone problems in cancer. The approval puts up a strong challenge to Amgen Inc.’s Prolia, the first biologic for osteoporosis, and Xgeva, for bone cancer.
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
Abbvie Inc.’s blockbuster drug Humira is getting a 10th challenger that could give all the other adalimumab biosimilars a run for their money – depending on pricing and formulary coverage, of course. After delays caused by the COVID-19 pandemic and manufacturing issues, the U.S. FDA approved Simlandi, previously known as AVT-02, as a Humira biosimilar and interchangeable Feb. 23.
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