Prolia® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva’s robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such [...]
SEOUL, Aug. 25 (Korea Bizwire) — South Korea’s major pharmaceutical firm Celltrion Inc. said Friday it has completed a license deal with Johnson & Johnson to sell its autoimmune disease treatment biosimilar in the United States. The deal will allow Celltrion’s CT-P43, the company’s ustekinumab biosimilar referencing Stelara, developed by J&J’s pharmaceutical unit of Janssen [...]
SEOUL, Sept. 27 (Korea Bizwire) — South Korean biopharmaceutical firm Celltrion Inc. said Tuesday it has received approval to sell its anticancer biosimilar Vegzelma in Japan. According to the company, Japan’s Ministry of Health, Labor and Welfare recently approved the sale of the biosimilar, also known as CT-P16, which referenced Switzerland-based Roche Holding’s blockbuster pill [...]
SEOUL, July 20 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. was in the process of acquiring regulatory approval from European and South Korean drug authorities for SB12, a paroxysmal nocturnal hemoglobinuria (PNH) treatment biosimilar candidate, industry sources said Wednesday. The company has submitted approval applications for SB12, a more affordable version of [...]
SEOUL, April 27 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Wednesday it will begin sales of its autoimmune disease biosimilar Yuflymain in the United States in July 2023. The plan comes as Celltrion has settled a patent dispute with U.S. drugmaker AbbVie Inc. Yuflyma — a biosimilar referencing blockbuster drug Humira — [...]
SEOUL, March 2 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Wednesday that its autoimmune disease biosimilar Yuflyma has begun sales in the domestic market. Yuflyma — a biosimilar referencing blockbuster drug Humira by AbbVie Inc. — is used to treat patients with multiple chronic inflammatory diseases, such as rheumatoid arthritis and psoriasis. [...]
SEOUL, Feb. 22 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Tuesday that a high-concentration version of its autoimmune disease biosimilar Yuflyma has won approval from European drug authorities. The European Medicines Agency (EMA) gave the green light to Celltrion’s application to sell Yuflyma — a biosimilar referencing blockbuster drug Humira by AbbVie [...]
SEOUL, Feb. 14 (Korea Bizwire) — Sales of the biosimilar Remsima by Celltrion Inc. reached an all-time high last year in the United States, the company said Monday. Sales of the biosimilar drug to treat autoimmune diseases jumped 13 percent on-year to US$385 million in 2021, Celltrion Healthcare said, citing industry data. Remsima references Janssen [...]
SEOUL, Dec. 30 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Thursday its new biosimilar of the arthritis drug Humira has won approval from Canadian authorities. Yuflyma, an adalimumab biosimilar with a high concentration, is used to treat patients with rheumatoid arthritis, psoriasis and inflammatory diseases. Yuflyma requires only half the solution administered [...]
SEOUL, June 15 (Korea Bizwire) — South Korean pharmaceutical firm Samsung Bioepis Co. said Monday that it has won approvals in major countries to conduct clinical trials for its new ophthalmology biosimilar candidate. SB15 is a biosimilar candidate referencing Regeneron Pharmaceuticals Inc.’s Eylea, a blockbuster therapy to treat age-related (wet) macular degeneration (AMD). It is [...]