SANDOZ GROUP AG Sandoz AG has re-submitted the biosimilar drug EG12014 (Trastuzumab Biosimilar) of 150 mg powder for concentrate for solution for infusion Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) on June 13, 2024 the US time. The name or code of new drug:EG12014 (trastuzumab biosimilar). Content of use/indication: The treatment of HER2 overexpressing early breast cancer, metastatic breast cancer, and metastatic gastric cancer.
(/ct2/show/NCT03433313?term= EG12014&draw=2&rank=1). Research and development plans: Re-submit the biosimilar drug EG12014 (Trastuzumab Biosimilar) of 150 mg powder for concentrate for solution for infusion Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA). Ongoing research and development: A. Filing an application /Approval/Disapproval/Results of different phase of human clinical trials (including interim analysis) /Any major events affecting the development of new drugs: Re-submit the biosimilar drug EG12014 (Trastuzumab Biosimilar) of 150 mg powder for concentrate for solution for infusion Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA).
Further steps when receiving approval from regulatory authorities, or the results of any phase of human clinical trials (including interim analysis) has statistical significance or other major events affecting the development of new drugs: (such as continuing in development, authorizing to others for sale, etc.): Received the approval letter from the Ministry of Health and Welfare for the biosimilar drug EIRGASUN 150 mg powder for concentrate for infusion in May 2023. Received the approval letter from EC for Herwenda-Trastuzumab biosimiliar EG12014 (150 mg, for intravenous use) in November 2023. EirGenix signed a license to Sandoz AG for the right to commercialize its breast cancer biosimilar drug, EG12014 (trastuzumab biosimilar), in the authorized markets.
The contract includes up-front payment, milestone payment at each stage, and profit-sharing royalty on product sales in the authorized markets in proportion to the ratios specified in the contract. The development phase will be further carried out: Estimated completion time: The actual review time and approval or rejection are within the authority of US FDA. Final decision will be based on the formal notification from FDA.
