The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers.
On August 25, 2023, Sandoz announced that the FDA has approved its biosimilar Tyruko® (natalizumab-sztn), developed by Polpharma Biologics. Tyruko® injection is the first and only FDA-approved.
FRANKFURT (Reuters) -Novartis' generic-drugs unit Sandoz said on Monday it plans to launch a generic version of Johnson & Johnson's anti-inflammatory drug Stelara under a collaboration deal with Samsung Bioepis. For Sandoz, which is due to become an independent company early next month, the transaction means more investment in the growing market of biosimilars, which are lower-cost copies of complex biotech drugs that have lost patent protection.
The reference medicine Stelara (ustekinumab) is a monoclonal antibody medication to interleukin (IL)-12/23 for the treatment of autoimmune disorders including Crohn s disease, plaque psoriasis,.