Samsung Bioepis announced on April 23 that it has received final marketing authorization from the European Commission (EC) for Pyzchiva (project name SB17, ustekinumab), a biosimilar to Stelara. Pyzchiva’s active substance name is ustekinumab.Pyzchiva is the fourth autoimmune disease treatment devel
Celltrion announced on April 11 that “Zymfentra” (the U.S. brand name for Remsima), the world’s first subcutaneous formulation of infliximab for the treatment of autoimmune diseases developed in-house, has completed its formulation patent registration with the United States Patent and Trademark Offi
Celltrion announced on March 25 that it has received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for the full label of its Xolair (active ingredient: omalizumab) biosimilar “CT-P39.”The original
Celltrion announced on March 11 that it has completed the application process for U.S. Food and Drug Administration (FDA) approval of “CT-P39,” a biosimilar to the asthma and chronic idiopathic urticaria treatment XOLAIR. The company applied for product approval based on the results of a global Phas
Samsung Bioepis announced on March 10 the clinical results of SB5, a biosimilar to the blockbuster drug Humira, at the American Academy of Dermatology (AAD) Annual Meeting held in San Diego, California, in the U.S. on Feb. 8 (local time). This study aimed to verify whether SB5 can be interchangeably
Samsung Bioepis announced on Feb. 25 that it has obtained a positive opinion for the sale of its biosimilar of Stelara, known as Pyzchiva, from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).The original drug of Pyzchiva developed by Janssen, know
Celltrion is expanding its market presence in Peru, a major Latin American country, by winning a series of successful public tenders.First of all, Truxima (rituximab) 500 mg won a tender held by the National Health Ministry of Peru (Centro Nacional de Abastecimiento de Recursos Estratégicos en Salud
Celltrion announced on Feb. 6 that Rani Therapeutics (Rani) in the United States has confirmed positive topline results in the Phase 1 clinical trial of oral ustekinumab (development name: RT-111). RT-111 is an oral formulation of Celltrion’s Stelara biosimilar, CT-P43, currently under development.I
The pharmaceutical patent disputes between domestic biosimilar companies and original pharmaceutical firms are escalating.According to industry sources on Jan. 31, Samsung Bioepis and Celltrion are embroiled in patent disputes with original pharmaceutical companies.Alexion Pharmaceuticals, a subsidi
Celltrion announced on Jan. 29 that it has completed its application to the U.S. Food and Drug Administration (FDA) for the approval of CT-P47, a biosimilar to the autoimmune disease treatment drug Actemra (ingredient name: tocilizumab). The application was based on the results of a global Phase 3 c
Celltrion has launched an 80-mg dosage form of its biosimilar Yuflyma (adalimumab) for the treatment of autoimmune diseases in the United States.Celltrion said on Jan. 17 that 80 mg is the same high-concentration (100 mg/ml) formulation as the 40 mg version that became available in the United States
Celltrion’s biosimilar products for the treatment of autoimmune diseases have successively won bids in major European countries.According to Celltrion on Jan. 12, Yuflyma (active ingredient: adalimumab) has successfully won a government bid in Italy. Yuflyma was awarded in the adalimumab government
On Dec. 28, the integrated company Celltrion will be officially launched. Celltrion is taking steps to leap into a global big pharmaceutical firm by merging with Celltrion Healthcare, which is responsible for global distribution.Celltrion and Celltrion Healthcare announced on Dec. 27 that they are i
Celltrion revealed on Dec. 26 that its biosimilar for autoimmune diseases, Yuflyma (CT-P17), has demonstrated equivalence and safety compared to the original drug, Humira.Developed by the American company AbbVie, Humira recorded sales of approximately US$21 brillion last year, making it the world’s
Celltrion announced on Dec. 18 that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for a Phase 1 clinical trial plan (IND) for CT-P55, a biosimilar of the psoriasis treatment Cosentyx (active ingredient: secukinumab).CT-P55 is a new autoimmune disease bi
Celltrion Healthcare is expanding its presence in the United States, the world's largest pharmaceutical market, with its biosimilar of Avastin for metastatic colorectal and breast cancer, known as Vegzelma (active ingredient: bevacizumab).On Dec. 12, Celltrion Healthcare announced that Vegzelma was
Celltrion announced on Nov. 30 (local time) that it has completed the application for product licensing with the U.S. Food and Drug Administration (FDA) for its biosimilar CT-P41 of the osteoporosis medication Prolia-Xgeva (active ingredient: denosumab).Based on the results of global Phase 3 clinica
The author is an analyst for NH Investment & Securities. He can be reached at pk.park@nhqv.com -- Ed.Celltrion Healthcare posted sound 3Q23 earnings, when considering purchase price settlements. Defying market concerns, the company showed a relative return of 15%p following its merger disclosure on
Chong Kun Dang announced on Nov. 6 that it has entered into a technology export agreement with Novartis worth US$1.305 billion for its new drug candidate CKD-510.Under the agreement, Novartis obtains exclusive rights outside of South Korea for the development and commercialization of CKD-510, a low-
In March 2021, Seo Jung-jin, the honorary chairman of Celltrion, declared his retirement, stating, “If there are any deficiencies in management, I will be prepared to play a firefighter’s role.” However, just two years later, in March of this year, he made a surprising announcement of his return to