The Delhi High Court has allowed Zydus Lifesciences to sell and market its biosimilar version of the anti-cancer drug nivolumab in India, despite a patent infringement suit filed by the innovator and patent holder, E.R. Squibb & Sons LLC. The court modified a previous order that had restrained the launch of Zydus’ biosimilar, citing public interest and the fact that the patent is set to expire on May 2, 2026. The bench of justices C. Hari Shankar and Om Prakash Shukla permitted continued sales of the biosimilar, directing Zydus to maintain detailed and audited records of its sales during this period so that Squibb can be compensated if it ultimately succeeds in the patent infringement suit.<\/p>\n
Nivolumab is a life-saving cancer drug used to treat several types of cancer, including lung and head and neck cancer. The drug is expensive, with a vial costing between \u20b921,500 to over \u20b91,00,000, making affordability a concern. The dispute began when Squibb approached the Delhi High Court in 2024, alleging that Zydus was preparing to launch a biosimilar version of nivolumab before the expiry of its Indian patent. Squibb claimed that Zydus had developed a biosimilar, applied for regulatory approvals, and conducted clinical trials, indicating an imminent commercial launch during the patent term.<\/p>\n
Zydus argued that its product did not infringe the patent and that it was developing a biosimilar in accordance with regulatory norms. The company also pointed to a pending post-grant opposition against Squibb’s patent filed by its group company. The court’s decision is a relief for Zydus and is expected to increase access to the life-saving drug for cancer patients in India. The court’s order also highlights the importance of balancing the rights of patent holders with the need to ensure access to affordable medicines, particularly in cases where the patent is nearing expiry.<\/p>\n
The case is significant as it involves a biosimilar version of a critical cancer drug, and the court’s decision has implications for the pharmaceutical industry and patients in India. The court’s order is also a testament to the Indian judiciary’s commitment to ensuring that patent laws are balanced with the need to provide access to affordable medicines. The decision is expected to have a positive impact on the availability and affordability of cancer treatments in India, where the rate of cancer incidence is on the rise.<\/p>\n","protected":false},"excerpt":{"rendered":"
The Delhi High Court has allowed Zydus Lifesciences to sell and market its biosimilar version of the anti-cancer drug nivolumab in India, despite a patent infringement suit filed by the innovator and patent holder, E.R. Squibb & Sons LLC. The court modified a previous order that had restrained the launch of Zydus’ biosimilar, citing public […]<\/p>\n","protected":false},"author":1,"featured_media":88150,"comment_status":"","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","fifu_image_url":"","fifu_image_alt":"","_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[2,19],"tags":[],"class_list":["post-89789","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma","category-zydus"],"jetpack_featured_media_url":"https:\/\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":89795,"url":"https:\/\/smallnews.in\/pharmaceuticals\/2026\/01\/13\/the-delhi-high-court-has-granted-permission-to-zydus-to-market-a-more-affordable-biosimilar-version-of-the-cancer-medication-nivolumab-citing-public-interest\/","url_meta":{"origin":89789,"position":0},"title":"The Delhi High Court has granted permission to Zydus to market a more affordable biosimilar version of the cancer medication Nivolumab, citing public interest.","author":"Team Small News","date":"January 13, 2026","format":false,"excerpt":"The Delhi High Court has given a significant ruling in favor of Zydus, a pharmaceutical company, allowing it to sell a biosimilar version of the cancer drug Nivolumab at a lower price. Nivolumab, marketed under the brand name Opdivo by Bristol Myers Squibb, is a monoclonal antibody used to treat\u2026","rel":"","context":"In "Pharma"","block_context":{"text":"Pharma","link":"https:\/\/smallnews.in\/pharmaceuticals\/category\/pharma\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":89869,"url":"https:\/\/smallnews.in\/pharmaceuticals\/2026\/01\/27\/zydus-lifesciences-introduces-indias-first-biosimilar-version-of-nivolumab-a-global-breakthrough\/","url_meta":{"origin":89789,"position":1},"title":"Zydus Lifesciences introduces India’s first biosimilar version of Nivolumab, a global breakthrough.","author":"Team Small News","date":"January 27, 2026","format":false,"excerpt":"Zydus Lifesciences, a leading life sciences company, has launched the world's first biosimilar of nivolumab in India under the brand name Tishtha. This milestone marks a significant expansion of patient access to cutting-edge cancer therapies, particularly in the field of Immuno-Oncology. Tishtha will be available in two dosage strengths, 100\u2026","rel":"","context":"In "Pharma"","block_context":{"text":"Pharma","link":"https:\/\/smallnews.in\/pharmaceuticals\/category\/pharma\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":89683,"url":"https:\/\/smallnews.in\/pharmaceuticals\/2025\/12\/19\/zydus-lifesciences-partners-to-introduce-diagnostic-tests-for-cancer-risk-evaluation-in-indian-market\/","url_meta":{"origin":89789,"position":2},"title":"Zydus Lifesciences Partners to Introduce Diagnostic Tests for Cancer Risk Evaluation in Indian Market","author":"Team Small News","date":"December 19, 2025","format":false,"excerpt":"Zydus Lifesciences Limited is a global life sciences company based in India that is involved in the discovery, development, manufacture, and marketing of a wide range of healthcare therapies. The company operates in the business of integrated pharmaceutical operations, offering a diverse product portfolio that includes active pharmaceutical ingredients (API),\u2026","rel":"","context":"In "Pharma"","block_context":{"text":"Pharma","link":"https:\/\/smallnews.in\/pharmaceuticals\/category\/pharma\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":89806,"url":"https:\/\/smallnews.in\/pharmaceuticals\/2026\/01\/15\/us-sales-of-revlimid-decline-offset-by-strong-domestic-market-growth\/","url_meta":{"origin":89789,"position":3},"title":"US Sales of Revlimid Decline, Offset by Strong Domestic Market Growth","author":"Team Small News","date":"January 15, 2026","format":false,"excerpt":"The Indian pharmaceutical industry is bracing for a challenging earnings season in Q3, with expectations of muted margins due to the loss of patent exclusivity for the blockbuster blood cancer drug Revlimid in the US. Revlimid, which has generated over $100 billion in global sales, has been a significant revenue\u2026","rel":"","context":"In "Cipla"","block_context":{"text":"Cipla","link":"https:\/\/smallnews.in\/pharmaceuticals\/category\/cipla\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":89690,"url":"https:\/\/smallnews.in\/pharmaceuticals\/2025\/12\/20\/zydus-lifesciences-partners-with-myriad-genetics-to-introduce-cutting-edge-cancer-diagnostic-solutions-in-india\/","url_meta":{"origin":89789,"position":4},"title":"Zydus Lifesciences Partners with Myriad Genetics to Introduce Cutting-Edge Cancer Diagnostic Solutions in India.","author":"Team Small News","date":"December 20, 2025","format":false,"excerpt":"Zydus Lifesciences Limited, a global life sciences company, has partnered with US-based Myriad Genetics to introduce advanced cancer-risk assessment and prognostic diagnostic tests in India. The exclusive agreement allows Zydus to offer Myriad's MyRisk Hereditary Cancer Test, MyChoice HRD Plus Test, and Prolaris Prostate Cancer Prognostic Test to patients, clinicians,\u2026","rel":"","context":"In "Pharma"","block_context":{"text":"Pharma","link":"https:\/\/smallnews.in\/pharmaceuticals\/category\/pharma\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/smallnews.in\/pharmaceuticals\/wp-content\/uploads\/sites\/6\/2025\/05\/Zydus-Logo.jpg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":89847,"url":"https:\/\/smallnews.in\/pharmaceuticals\/2026\/01\/24\/us-fda-concludes-inspection-at-zydus-ankleshwar-facility-with-three-noted-observations\/","url_meta":{"origin":89789,"position":5},"title":"US FDA Concludes Inspection at Zydus’ Ankleshwar Facility with Three Noted Observations.","author":"Team Small News","date":"January 24, 2026","format":false,"excerpt":"The US Food and Drug Administration (USFDA) has completed an inspection at Zydus Cadila's manufacturing facility in Ankleshwar, Gujarat, with three observations. The inspection was conducted from February 13 to February 17, 2023. 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