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 [...]
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 [...]
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 [...]
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 [...]
SEOUL, Jan. 23 (Korea Bizwire) — Celltrion Inc.’s autoimmune disease treatment, SteQeyma, has been launched in five major European nations, the Korean company said Thursday. SteQeyma, an ustekinumab biosimilar treatment for multiple chronic inflammatory diseases, was released in France on Monday (local time), following its launch in Italy and Spain earlier this month, according to [...]
SEOUL, Dec. 9 (Korea Bizwire) — South Korea’s pharmaceutical giant Celltrion Inc. said Monday that it has received approval from Canadian health authorities for a biosimilar treatment for allergic asthma. The company said that its biosimilar, Omlyclo, a version of Xolair, has been approved by Health Canada, adding that studies have demonstrated its equivalent performance [...]
SEOUL, Aug. 16 (Korea Bizwire) — Celltrion Inc., a South Korean biopharmaceutical firm, said Friday it has decided not to merge with its chemical drug-producing affiliate, Celltrion Pharm Inc., as shareholders disagreed on the planned merger. The decision was made in board meetings of the two companies held earlier in the day, Celltrion said. In [...]
SEOUL, Apr. 23 (Korea Bizwire) — Celltrion Inc. saw the combined market share of its autoimmune biosimilar infliximab products, Remsima and Remsima SC, rising in five European nations, company officials said Tuesday. The combined market share of Remsima and the subcutaneous version of the drug hit 74 percent in Britain, Germany, France, Spain and Italy [...]
SEOUL, Mar. 18 (Korea Bizwire) — South Korean biopharmaceutical firm Celltrion Inc. said Monday its new autoimmune disease treatment, Zymfentra, has made a debut in the U.S. market. Zymfentra, a subcutaneous injection formulation of Celltrion’s infliximab Remsima, won approval from the U.S. Food and Drug Administration last year for use on patients who suffer ulcerative [...]
SEOUL, Nov. 30 (Korea Bizwire) — Celltrion Healthcare Co. said Thursday its new autoimmune disease treatment, Zymfentra, will make its U.S. market debut on Feb. 29 next year. Zymfentra, a subcutaneous injection formulation of Celltrion’s infliximab Remsima, won approval from the U.S. Food and Drug Administration last month. The sales affiliate of South Korean pharmaceutical [...]