biosimilar Archives | Be Korea-savvy
Celltrion Completes License Deal with J&J to Sell Autoimmune Biosimilar in U.S. in 2025

Celltrion Completes License Deal with J&J to Sell Autoimmune Biosimilar in U.S. in 2025

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 [...]

Celltrion Receives Approval to Sell Anticancer Biosimilar Vegzelma in Japan

Celltrion Receives Approval to Sell Anticancer Biosimilar Vegzelma in Japan

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 [...]

Samsung Bioepis’ Biosimilar Candidate SB12 Under Approval Review in Europe, S. Korea

Samsung Bioepis’ Biosimilar Candidate SB12 Under Approval Review in Europe, S. Korea

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 [...]

Celltrion’s Autoimmune Disease Biosimilar to Land in U.S. in July 2023

Celltrion’s Autoimmune Disease Biosimilar to Land in U.S. in July 2023

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 — [...]

Celltrion’s Autoimmune Disease Biosimilar Lands in S. Korea

Celltrion’s Autoimmune Disease Biosimilar Lands in S. Korea

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. [...]

Celltrion’s Autoimmune Disease Biosimilar Wins Further Approval in Europe

Celltrion’s Autoimmune Disease Biosimilar Wins Further Approval in Europe

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 [...]

Celltrion’s New Humira Biosimilar Wins Approval in Canada

Celltrion’s New Humira Biosimilar Wins Approval in Canada

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 [...]

Samsung Bioepis’ Ophthalmology Biosimilar Candidate Receives Clinical Approvals in 8 Markets

Samsung Bioepis’ Ophthalmology Biosimilar Candidate Receives Clinical Approvals in 8 Markets

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 [...]

Celltrion to Study Efficacy of Remsima on COVID-19 in Britain

Celltrion to Study Efficacy of Remsima on COVID-19 in Britain

SEOUL, June 10 (Korea Bizwire) — An affiliate of South Korean biopharmaceutical firm Celltrion Inc. said Wednesday that it will begin a study on the treatment efficacy of its biosimilar Remsima on the novel coronavirus. Celltrion Healthcare, which handles Celltrion’s overseas business, said the trial study of Remsima, a biosimilar drug to treat autoimmune diseases, [...]