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 various types of cancer, including melanoma, lung cancer, and kidney cancer. The court’s decision is expected to make the life-saving drug more accessible to patients in India.
Zydus had launched its biosimilar version of Nivolumab, called Itolizumab, in India, which is priced significantly lower than the original drug. However, Bristol Myers Squibb had approached the court, seeking an injunction to stop Zydus from selling the biosimilar, claiming that it infringed on their patent. The court, after hearing the arguments, ruled in favor of Zydus, stating that the company can continue to sell its biosimilar version of Nivolumab in the public interest.
The court’s decision is based on the fact that Nivolumab is a life-saving drug, and its high price makes it inaccessible to many patients in India. The court observed that the price of the original drug is exorbitant, and the biosimilar version launched by Zydus is priced at a significantly lower rate, making it more affordable for patients. The court also noted that Zydus has invested significant resources in developing the biosimilar and has obtained all necessary regulatory approvals.
The ruling is a significant win for patients in India, who will now have access to a more affordable version of the life-saving drug. The decision is also expected to have a positive impact on the Indian pharmaceutical industry, as it will encourage other companies to develop and launch biosimilars of expensive drugs, making them more accessible to patients.
The court’s decision is in line with the government’s efforts to make healthcare more affordable and accessible to all. The government has been promoting the use of biosimilars and generic drugs to reduce the cost of healthcare and make life-saving drugs more accessible to patients. The ruling is also expected to set a precedent for future cases, where pharmaceutical companies may approach the court to stop the sale of biosimilars, citing patent infringement. Overall, the court’s decision is a significant step towards making healthcare more affordable and accessible to all in India.