Celltrion Archives | Be Korea-savvy
Celltrion Wins U.S. FDA Approval for Eye-Disease Biosimilar Eydenzelt

Celltrion Wins U.S. FDA Approval for Eye-Disease Biosimilar Eydenzelt

SEOUL, Oct. 10 (Korea Bizwire) – Celltrion Inc., a leading South Korean biopharmaceutical company, said Friday its biosimilar for eye diseases has received approval for sale in the United States. The U.S. Food and Drug Administration (FDA) has approved Eydenzelt, Celltrion’s biosimilar referencing Eylea, for the treatment of wet age-related macular degeneration and other ophthalmic [...]

Celltrion Aims To Strengthen Biosimilar Lineup In Vietnam

Celltrion Aims To Strengthen Biosimilar Lineup In Vietnam

SEOUL, Aug. 28 (Korea Bizwire) — Celltrion Inc., a leading South Korean biopharmaceutical company, said Thursday it will strengthen its biosimilar lineup in Vietnam to meet rising demand in the Southeast Asian country. Celltrion launched two biosimilars in Vietnam this year — Remsima, for the treatment of autoimmune diseases, in June, and Herzuma, for breast [...]

Celltrion Expects Limited Impact from U.S. Executive Order on Price Reduction

Celltrion Expects Limited Impact from U.S. Executive Order on Price Reduction

SEOUL, May 21 (Korea Bizwire) — Celltrion Inc., a leading South Korean biopharmaceutical company, said Wednesday it expects limited impact from recent U.S. policy developments stemming from a drug pricing executive order signed by President Donald Trump. Last week, Trump announced an executive order introducing a most-favored nation (MFN) pricing model, intended to align U.S. [...]

Celltrion Expects Minimal Impact from Trump’s Drug Pricing Order

Celltrion Expects Minimal Impact from Trump’s Drug Pricing Order

SEOUL, May 15 (Korea Bizwire) — Celltrion Inc., a leading South Korean biopharmaceutical company, said Thursday its business will remain largely unaffected by U.S. President Donald Trump’s executive order aimed at lowering drug prices to match those in other countries. The order seeks to address a drug pricing system in which the United States pays [...]

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 [...]

Celltrion Launches Autoimmune Disease Treatment in U.S.

Celltrion Launches Autoimmune Disease Treatment in U.S.

SEOUL, March 13 (Korea Bizwire) — Celltrion Inc., a major South Korean biopharmaceutical firm, said Thursday it has launched its biosimilar product for Stelara, an autoimmune disease treatment, in the United States. Steqeyma, a treatment for plaque psoriasis, Crohn’s disease, active psoriatic arthritis and ulcerative colitis, is Celltrion’s seventh biosimilar product that has hit the [...]

Celltrion Gets U.S. Approval for Allergic Asthma Biosimilar

Celltrion Gets U.S. Approval for Allergic Asthma Biosimilar

SEOUL, March 10 (Korea Bizwire) — Celltrion Inc., a major South Korean biopharmaceutical firm, said Monday its biosimilar for asthma and other chronic allergic diseases has obtained approval for U.S. sales. The U.S. Food and Drug Administration (FDA) approved Celltrion’s Omlyclo, a biosimilar drug to Xolair, for treatment of moderate to severe persistent asthma, chronic [...]

Celltrion’s Autoimmune Disease Treatment Gets Approval in Europe

Celltrion’s Autoimmune Disease Treatment Gets Approval in Europe

SEOUL, Feb. 24 (Korea Bizwire) — Celltrion Inc., a major South Korean biopharmaceutical firm, said Monday its new biosimilar for an autoimmune disease treatment has obtained approval from the European Commission (EC). The EC approved Celltrion’s Avtozma, a biosimilar to Actemra, in both intravenous and subcutaneous formulations, for sales in the member countries of the [...]

Celltrion Gets U.S. FDA Approval for New Biosimilar for Autoimmune Disease Treatment

Celltrion Gets U.S. FDA Approval for New Biosimilar for Autoimmune Disease Treatment

SEOUL, Jan. 31 (Korea Bizwire) — Celltrion Inc., a major South Korean biopharmaceutical firm, said Friday its new biosimilar for an autoimmune disease treatment has received approval from the U.S. Food and Drug Administration (FDA). The FDA approved Celltrion’s Avtozma, a biosimilar to Actemra, in both intravenous and subcutaneous formulations, according to the company. Avtozma [...]