Celltrion Secures Dominant Market Share in Asia Led by Autoimmune and Oncology Biosimilars
Celltrion is consolidating its leading market position across major Asian countries with its key autoimmune and oncology therapies.
Search results for "biosimilar"
Samsung Bioepis Seeks South Korean Approval for Keytruda Biosimilar SB27
Samsung Bioepis announced on Aug. 10 that it has submitted a marketing authorization application to South Korea's Ministry of Food and Drug Safety...
Celltrion Files for EU Approval of Cosentyx Biosimilar CT-P55, Targeting $6.7 Billion Autoimmune Market
Celltrion announced on the 24th that it has submitted a marketing authorization application to the European Medicines...
Celltrion Secures South Korean Phase 1 Approval for Tremfya Biosimilar CT-P68
Celltrion announced on July 15 that it has received approval from South Korea’s Ministry of Food and Drug Safety for an...
Fast-Tracking Biosimilars: South Korea to Waive Phase 3 Clinical Trials Under New Guidelines
South Korean regulators have revised requirements to significantly reduce the time and financial burden of biosimilar...
Celltrion Secures Japanese Approval for Xolair and Eylea Biosimilars
Celltrion announced on the 27th that it has obtained marketing authorization from Japan’s Ministry of Health, Labour...
Alteogen Poised for Surge in Milestone Revenue as Keytruda Qlex and Biosimilars Gain Momentum
Alteogen is set to accelerate its financial growth this year, driven by a surge in milestone payments and royalty...
Samsung Bioepis Set to Launch Eylea Biosimilar in the U.S. Next January
Samsung Bioepis announced on the 12th that it has entered into a patent license agreement with the original developer...
Samsung Bioepis Aflibercept Biosimilar Available for Sale in Europe
Samsung Bioepis announced on the 30th that it has signed a patent agreement and licensing contract with the original...
Celltrion Secures Historic FDA Interchangeability Status for Truxima
Celltrion announced on the 1st that the U.S. Food and Drug Administration has granted interchangeable status to Truxima...