nivolumab biosimilar / Lupin - LARVOL DELTA

Lupin gets CDSCO nod for nivolumab biosimilar (ExpressPharma) - "The approval, granted earlier this week, extends to the indications authorised for the innovator product and is backed by a local phase 3 study undertaken by Lupin to establish its efficacy, immunogenicity and pharmacokinetics with the innovator....Lupin has been asked to conduct a Phase IV study to further evaluate the biosimilar's safety and efficacy in real-world clinical settings."

Approval • dMMR • MSI-H • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Hodgkin Lymphoma • Malignant Pleural Mesothelioma • Melanoma • Non Small Cell Lung Cancer • Peritoneal Mesothelioma • Renal Cell Carcinoma • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer