EMA Accepts Marketing Authorization Application for DMB-3115, a Stelara Biosimilar by Dong-A ST   Confirmation of Therapeutic Equivalence and Safety between DMB-3115 and Stelara in Global Phase III Trial   SEOUL, South Korea--(BUSINESS WIRE)-- On July 14, Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced that the European Medicine Agency (EMA) has accepted the Marketing Autho..
Dr. Reddy's Laboratories Ltd., a global pharmaceutical company based in Hyderabad, India, has reached a significant milestone in its pursuit of bringing a biosimilar rituximab to market. The company's proposal for the rituximab biosimilar, known as DRL_RI, has been accepted for review by multiple regulatory agencies.   In January 2023, Dr. Reddy's Laboratories announced the successful comple..
Fresenius Kabi, a global healthcare company specializing in medicines and technologies, has announced the availability of its first immunology biosimilar, IDACIO® (adalimumab-aacf), in the United States. IDACIO® is indicated for use in the treatment of chronic autoimmune diseases and is a biosimilar to Humira® (adalimumab). It is available in a self-administered prefilled syringe and pre-filled ..
Johnson & Johnson (J&J) has settled with Teva and Alvotech over the biosimilar to its most lucrative asset, Stelara. The deal allows AVT04 to enter the US market no later than February 2025. This follows a May 2023 agreement with Amgen over ABP 654, which will hit markets no later than January 1, 2025. Stelara is a human IgG1k monoclonal antibody that targets the IL-12 and IL-23 cytokines. Its p..
