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Home » Topics » Drugs » Biosimilar

Biosimilar
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Headquarter building for Alteogen

Alteogen stock rebounds after ex-CSO sells 3% stake in block deal

April 2, 2024
By Marian (YoonJee) Chu
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.
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Headquarter building for Alteogen

Alteogen stock rebounds after ex-CSO sells 3% stake in block deal

March 28, 2024
By Marian (YoonJee) Chu
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.
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Rendering of Milliporesigma's new bioprocessing production center in Daejeon, South Korea

Merck pours €300M+ in S. Korea as big pharma ups Asia investment

March 26, 2024
By Marian (YoonJee) Chu
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.
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Rendering of Milliporesigma's new bioprocessing production center in Daejeon, South Korea

Merck pours €300M+ in S. Korea as big pharma ups Asia investment

March 21, 2024
By Marian (YoonJee) Chu
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.
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Celltrion files for US approval of Xolair biosimilar, CT-P39

March 12, 2024
By Marian (YoonJee) Chu
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.
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Celltrion files for US approval of Xolair biosimilar, CT-P39

March 11, 2024
By Marian (YoonJee) Chu
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.
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Drug vials and syringe

Sandoz’s denosumab biosimilars challenge Amgen with US FDA nod

March 6, 2024
By Lee Landenberger
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.
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Scientists working in Samsung Bioepis lab

Keytruda biosimilars ramp up; Samsung Bioepis starts phase I

Feb. 27, 2024
By Marian (YoonJee) Chu
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.
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Injection syringes

Teva, Alvotech land approval with edge in Humira biosimilar race

Feb. 26, 2024
By Mari Serebrov
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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Scientists working in Samsung Bioepis lab

Keytruda biosimilars ramp up; Samsung Bioepis starts phase I

Feb. 21, 2024
By Marian (YoonJee) Chu
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.
Read More
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