Tishtha (nivolumab biosimilar) / Zydus Lifesciences - LARVOL DELTA

The Supreme Court on Wednesday refused to stop Zydus Lifesciences from proceeding with the manufacture and sale of its biosimilar version of the cancer drug nivolumab, sold globally by US-based Bristol Myers Squibb (BMS) under the brand Opdivo. (Business Standard) - "At the same time, the Court asked BMS to undertake a detailed mapping of Zydus’ product concerning its patent claims and seek appropriate interim relief before the Delhi High Court, depending on the outcome of that exercise...Zydus, however, maintained that its biosimilar would reduce treatment costs by nearly 70 per cent compared with the innovator product, and argued that its formulation does not violate BMS’ patent. It also pointed out that the patent itself is under challenge, with a post-grant opposition pending through a group entity."

dMMR • Patent • Bladder Cancer • Classical Hodgkin Lymphoma • Colorectal Cancer • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Lung Non-Squamous Non-Small Cell Cancer • Malignant Pleural Mesothelioma • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Urothelial Cancer

Bristol Myers moves SC to stop Zydus from selling biosimilar cancer drug (The Economic Times) - "The top court will hear BMS firm ER Squibb's appeal against Zydus Lifesciences on February 4...It has challenged the Delhi High Court's January 12 order that cleared the way for Zydus to market and sell a biosimilar version of nivolumab...The US company had moved the court in 2024 alleging patent infringement by Zydus...While citing public interest that nivolumab is a life-saving drug, the high court said the balance of convenience lies in permitting the biosimilar's sale for the remaining term of Squibb's patent, which will expire on May 2....The Indian company had argued that its product, ZRC-3276, did not infringe the patent, that the patent itself was open to challenge, and that it was developing a biosimilar in accordance with regulations."

dMMR • Patent • Bladder Cancer • Classical Hodgkin Lymphoma • Colorectal Cancer • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Lung Non-Squamous Non-Small Cell Cancer • Malignant Pleural Mesothelioma • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Urothelial Cancer

Zydus launches the world’s first biosimilar of Nivolumab, ‘Tishtha’, in India to treat multiple cancers (ExpressPharma) - "Tishtha will be available in 100 mg and 40 mg dosages priced at ₹28,950 and ₹13,950 respectively. The prices are approximately 1/4th of the reference drug. This will improve affordability and reduce the overall treatment burden for patients."

Biosimilar launch • dMMR • MSI-H • Pricing • Bladder Cancer • Classical Hodgkin Lymphoma • Colorectal Cancer • Esophageal Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Delhi HC Clears Zydus' Cancer Drug ZRC-3276 Despite BMS Patent Claim (Medical Dialogues) - "Zydus Lifesciences argued that although its product was a biosimilar of Nivolumab for regulatory purposes, it did not fall within the scope of the patent claims because it did not bind exclusively to PD-1 and showed statistically significant binding with other proteins belonging to the CD-28 family...The company argued that Bristol Myers Squibb had failed to map ZRC-3276 to the claims of Patent IN 340060, a requirement expressly mandated by Rule 3 (A)(ix) of the Delhi High Court Patent Suits Rules, 2022....With this ruling, the Delhi High Court has reaffirmed that patent enforcement must be grounded in strict claim analysis and balanced against public interest, especially where access to essential medicines and patient lives are at stake."

dMMR • Patent • Bladder Cancer • Classical Hodgkin Lymphoma • Colorectal Cancer • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Lung Non-Squamous Non-Small Cell Cancer • Malignant Pleural Mesothelioma • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Urothelial Cancer