biosimilar Archives | Be Korea-savvy
Korean Biosimilar Makers Intensify Global Battle for First-Mover Advantage

Korean Biosimilar Makers Intensify Global Battle for First-Mover Advantage

SEOUL, Sept. 29 (Korea Bizwire) — South Korea’s biosimilar industry is ramping up competition at home and abroad, with companies racing to secure early approvals, expand sales networks, and leverage artificial intelligence as differentiators in a crowded market. At least six biosimilars won approvals or launches globally this month alone, underscoring the pace of expansion. Celltrion [...]

Biosimilar Competition and Patent Expirations Top Concerns for Global Pharma Leaders, Survey Finds

Biosimilar Competition and Patent Expirations Top Concerns for Global Pharma Leaders, Survey Finds

SEOUL, April 22, (Korea Bizwire) — Intensifying competition from biosimilars and the looming expiration of lucrative drug patents have emerged as the foremost concerns for global pharmaceutical, biotech, and medical device companies, according to a 2025 report by Deloitte Korea. The report, titled “Five Key Challenges for the Global Pharmaceutical and Biotech Industry in 2025,” [...]

Celltrion Gets Interchangeability Approval for Biosimilar of Humira in U.S.

Celltrion Gets Interchangeability Approval for Biosimilar of Humira in U.S.

SEOUL, April 14 (Korea Bizwire) — Celltrion Inc., a major South Korean biopharmaceutical firm, said Monday it has obtained an interchangeability approval for its biosimilar drug for autoimmune disease treatment in the United States. The U.S. Food and Drug Administration (FDA) designated Celltrion’s biosimilar Yuflyma as interchangeable medicine for its original drug Humira in the [...]

Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA

Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA

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 [...]

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. [...]