Delhi High Court grants permission to Zydus to market Nivolumab biosimilar, a cancer treatment drug, in India.
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.
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 ₹21,500 to over ₹1,00,000, 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.
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.
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.
Alkem’s Renocia kit offers a cyclical nutritional supplement therapy designed to promote healthy hair growth.
Alkem Laboratories has launched a new product called Renocia cyclical therapy kit, a weekly nutritional supplementation regimen designed to support hair growth, strengthen hair follicles, and manage hair loss. The kit contains a set of vegetarian-sourced supplements, including vitamins, minerals, and amino acids, which are taken on specific days of the week. This structured protocol allows for better nutrient absorption and utilization.
According to Dr. Vikas Gupta, CEO of Alkem, nutritional supplementation plays a crucial role in hair health, but outcomes can vary depending on nutrient selection, absorption, and long-term adherence. The Renocia cyclical therapy kit offers a targeted approach that aligns with the body’s natural nutritional requirements throughout the week. By using only vegetarian-sourced ingredients, the company aims to make the product accessible to all sections of the Indian population.
The kit is available in a convenient wallet pack that contains supplements for four weeks, with clear instructions on which tablets to take on each day. The product is formulated separately for men and women to cater to their specific nutritional needs. Renocia cyclical therapy is a prescription product, and Alkem has a growing portfolio of products in the dermatology segment, including skin and hair care products.
The Renocia brand offers a range of hair care products, including hair revitalizing shampoo, conditioner, serum, and oral supplements. The launch of the cyclical therapy kit is a significant addition to the brand’s portfolio, providing a comprehensive solution for hair care. With its scientifically-designed regimen and vegetarian-sourced ingredients, the Renocia cyclical therapy kit is poised to make a positive impact on the hair care market in India.
Overall, the Renocia cyclical therapy kit is a innovative product that offers a structured approach to hair care, providing a convenient and effective solution for individuals looking to support hair growth and manage hair loss. With its focus on vegetarian-sourced ingredients and separate formulations for men and women, the product is likely to appeal to a wide range of consumers in India.
Mylan and Aurobindo Pharma must defend against allegations of colluding to fix prices for generic drugs.
A federal judge in Connecticut has rejected a request by Mylan Pharmaceuticals and Aurobindo Pharma USA to dismiss antitrust litigation against them. The judge ruled that a coalition of states has presented sufficient evidence to raise a genuine dispute about whether the companies conspired to fix drug prices. This decision allows the litigation to proceed against Mylan and Aurobindo, as well as 24 other pharmaceutical companies.
The antitrust litigation alleges that the pharmaceutical companies engaged in a conspiracy to fix prices, which is a violation of federal and state antitrust laws. The coalition of states, which is leading the litigation, claims that the companies’ alleged conspiracy has resulted in higher drug prices for consumers.
The judge’s decision is a significant setback for Mylan and Aurobindo, which had sought to have the litigation dismissed. The companies had argued that the states lacked sufficient evidence to support their claims, but the judge disagreed. The decision means that the litigation will continue, and the companies will be required to defend themselves against the allegations.
The litigation is part of a larger effort by states and federal authorities to crack down on alleged anticompetitive practices in the pharmaceutical industry. The industry has faced numerous lawsuits and investigations in recent years, and several companies have already settled allegations of price-fixing and other anticompetitive behaviors.
The judge’s decision is a victory for the coalition of states, which is seeking to hold the pharmaceutical companies accountable for their alleged actions. The litigation is likely to continue for several years, and the outcome is uncertain. However, the decision to allow the litigation to proceed is a significant step forward for the states and consumers who are seeking relief from high drug prices.
The case is being closely watched by the pharmaceutical industry and legal experts, who are interested in the potential implications of the litigation. A victory for the states could result in significant changes to the way pharmaceutical companies operate, and could lead to lower drug prices for consumers.
Biocon Biologics enhances its cancer treatment offerings with the introduction of three key biosimilar products.
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Limited, has announced plans to expand its oncology portfolio with the introduction of three new biosimilar candidates. The new additions include biosimilar versions of Trastuzumab/Hyaluronidase, Nivolumab, and Pembrolizumab, which are used to treat various types of cancer. With these new additions, Biocon Biologics will offer one of the broadest oncology biosimilar portfolios in the industry, addressing some of the world’s highest-revenue biologics that are expected to lose exclusivity over the next five years.
The company’s oncology portfolio represents a market opportunity exceeding $75 billion, accounting for nearly 35% of the global oncology pharmaceutical market. Biocon Limited has also announced plans to integrate Biocon Biologics as a wholly owned subsidiary, which is expected to simplify the corporate structure, enhance global commercial leverage, and strengthen Biocon’s leadership across diabetes, oncology, and immunology.
The integration, which is targeted to be completed by March 31, 2026, subject to regulatory approvals, will enable Biocon to offer biosimilar insulins alongside complex peptide generics, addressing the full continuum of diabetes care. Biocon Biologics’ CEO and Managing Director, Shreehas Tambe, commented that the integration will significantly enhance the company’s ability to deliver high-quality, affordable medicines at scale.
Biocon Biologics is a fully integrated global biosimilars company that serves over 6.3 million patients across 120 countries, providing high-quality biosimilars at affordable costs. The company has commercialized 10 biosimilars to date and has a pipeline of over 20 biosimilar assets spanning various therapeutic areas. Biocon Biologics is committed to advancing environmental, social, and governance priorities aligned with the United Nations Sustainable Development Goals.
The company’s expansion into the oncology market is expected to improve access to affordable cancer treatments worldwide. Biosimilars have been shown to be effective in reducing the cost of biologic treatments, making them more accessible to patients who may not have been able to afford them otherwise. With its expanded portfolio, Biocon Biologics is well-positioned to play a significant role in the global oncology market. The company’s commitment to delivering high-quality, affordable medicines is expected to have a positive impact on patients and healthcare systems worldwide.
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