Latest News on Zydus Lifesciences
Zydus Lifesciences introduces India’s first biosimilar version of Nivolumab, a global breakthrough.
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 mg and 40 mg, priced at ₹28,950 and ₹13,950, respectively, which is approximately one-fourth of the reference product. This competitive pricing aims to improve treatment affordability and reduce the financial burden of cancer treatment.
The launch of Tishtha reinforces Zydus Lifesciences’ commitment to patient-centric care, with a focus on providing timely access to affordable and advanced cancer care. The company aims to support patients throughout their treatment journey, ensuring consistency, affordability, and reach. The development and manufacturing of Tishtha in India ensures long-term supply reliability, enabling patients to continue therapy without disruption.
The introduction of Tishtha in India significantly broadens access to advanced Immuno-Oncology treatments, making high-quality biosimilar immunotherapies accessible to a wider patient population. This launch is a pivotal step in Zydus Lifesciences’ efforts to make innovative, affordable healthcare solutions available to patients. By providing a reliable and consistent supply of Tishtha, the company aims to reduce clinical risk and financial stress associated with treatment interruptions.
According to Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences, every patient deserves timely access to affordable and advanced cancer care. The company’s commitment to patient access and affordability is reflected in the pricing of Tishtha, which is designed to minimize drug wastage and optimize dosing. With the launch of Tishtha, Zydus Lifesciences continues to play a leading role in advancing patient-centric Immuno-Oncology care in India, providing patients with access to innovative and affordable treatment options.
Several major Indian pharmaceutical companies, including Sun Pharma, Cipla, Zydus, and Graviti, have issued recalls for certain medications in the United States market.
Several major pharmaceutical companies, including Sun Pharma, Cipla, Zydus, and Graviti Pharmaceuticals, are recalling various products in the US due to manufacturing issues, according to recent US FDA enforcement reports. The recalls are primarily related to problems with impurities, quality control, and production processes.
Sun Pharma is recalling over 24,000 bottles of Fluocinolone Acetonide topical solution and Clindamycin Phosphate topical solution due to out-of-specification results for impurities and assay. Cipla is recalling more than 15,000 syringes of Lanreotide Injection, used to treat a rare hormonal condition, due to production issues at its Greek manufacturing partner, Pharmathen. The production of Lanreotide has been temporarily paused to address quality concerns, resulting in limited supply.
Additionally, Cipla is recalling over 92,000 tubes of Diclofenac Sodium Topical Gel due to failed pH specifications. Graviti Pharmaceuticals is recalling over 4,000 bottles of Furosemide Tablets due to the presence of a foreign substance. Zydus Pharmaceuticals is recalling over 22,000 bottles of Icosapent Ethyl capsules due to oxidation caused by leakage, which may lead to inconsistent therapeutic effects and increased gastrointestinal side effects.
These recalls highlight the importance of quality control and manufacturing standards in the pharmaceutical industry. The FDA’s enforcement actions aim to ensure that products meet strict safety and efficacy standards to protect public health. The recalls may result in temporary shortages of these products, and patients are advised to consult their healthcare providers for alternative treatments.
The recalls also underscore the need for pharmaceutical companies to maintain robust quality control systems and adhere to good manufacturing practices (GMPs) to prevent such issues. The companies involved are taking corrective actions to address the problems and prevent future occurrences. The FDA will continue to monitor the situation and take further action if necessary to ensure the safety and efficacy of pharmaceutical products in the US market.
Bengaluru to host Zydus Pinkathon after a 7-year hiatus
The Zydus Pinkathon, a prominent women’s running event, is set to return to Bengaluru on January 25, marking its eighth edition in the city after a seven-year hiatus. With an expected participation of over 5,000 women, the event aims to promote fitness and community engagement among women of all age groups and fitness levels. The event will feature various race categories, including 3 km, 5 km, and 10 km runs, as well as ultradistances of 50 km, 75 km, and 100 km, and a 100 km relay.
The Bengaluru edition is being supported by the Department of Youth Empowerment and Sports, Government of Karnataka, and has received institutional backing from the Sports Authority of India and Fit India. The event is designed to encourage women to adopt regular physical activity, particularly in a city like Bengaluru, which is known for its young, working population and high-pressure lifestyles.
Founded by Milind Soman in 2012, Pinkathon has positioned Bengaluru as a key city in its journey, citing the city’s strong running culture and growing focus on wellness. The event has become a significant part of the city’s fitness landscape, and its return is expected to be a major boost to the city’s running community.
The Zydus Pinkathon is part of the 2025-26 nationwide season, which will also include events in Hyderabad on February 15 and Delhi on March 8. The event’s organizers aim to use the platform to promote fitness-led community engagement and encourage women to prioritize their physical and mental well-being. With its diverse range of race categories and inclusive approach, the Zydus Pinkathon is expected to be a memorable and empowering experience for all participants. Overall, the return of the Zydus Pinkathon to Bengaluru is a significant development for the city’s fitness enthusiasts and a testament to the growing importance of women’s health and wellness in India.
US FDA Concludes Inspection at Zydus’ Ankleshwar Facility with Three Noted Observations.
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. Although the company has not provided detailed information about the observations, it has stated that they are not related to data integrity or repeat observations from previous inspections.
The Ankleshwar plant is a key manufacturing facility for Zydus Cadila, producing a range of pharmaceutical products, including injectables, oral solids, and topical formulations. The USFDA inspection is a critical step in ensuring compliance with regulatory requirements for products exported to the US market. The observations made by the USFDA are considered minor, and the company is expected to respond to them within a specified timeframe.
Zydus Cadila has a history of USFDA inspections at its various manufacturing facilities. In 2020, the company’s Moraiya facility received a warning letter from the USFDA, citing several observations related to quality control and manufacturing practices. However, the company has since taken corrective actions and has been working to improve its compliance with regulatory requirements.
The outcome of the recent inspection at the Ankleshwar plant is seen as a positive development for Zydus Cadila, as it indicates that the company is on the right track in terms of compliance with USFDA regulations. The company’s management has stated that it is committed to maintaining high standards of quality and compliance at all its manufacturing facilities.
The inspection outcome is also significant for the Indian pharmaceutical industry as a whole, as it demonstrates the country’s ability to produce high-quality pharmaceutical products that meet international regulatory standards. India is a major player in the global pharmaceutical industry, with many companies exporting products to the US and other countries.
In conclusion, the USFDA’s inspection at Zydus Cadila’s Ankleshwar plant with three observations is a positive development for the company and the Indian pharmaceutical industry. While the observations are minor, the company will need to respond to them promptly to ensure compliance with regulatory requirements. The inspection outcome highlights the importance of maintaining high standards of quality and compliance in the pharmaceutical industry, and Zydus Cadila’s commitment to these principles is expected to support its growth and success in the global market.
US Sales of Revlimid Decline, Offset by Strong Domestic Market Growth
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 and margin driver for Indian drugmakers such as Dr Reddy’s Laboratories, Cipla, Zydus Lifesciences, and Sun Pharma. However, with the patent expiry in January 2026, these companies will have to offload their remaining quotas, leading to a decline in sales.
Analysts expect a sector-wide decline in earnings before interest, taxes, depreciation, and amortization (Ebitda) margins by 150 basis points year-on-year, with companies such as Dr Reddy’s, Cipla, and Zydus Lifesciences likely to be affected. The decline in Revlimid sales will be a significant contributor to this margin pressure, with prices expected to erode sharply as players look to offload remaining quotas. Additionally, other factors such as increased generic price competition in the US market, higher research and development (R&D) expenses, and rising selling, general, and administrative (SG&A) costs will also weigh on margins.
Despite these challenges, analysts remain optimistic about the sector’s overall revenue growth, with expectations of 8-11% growth driven by steady domestic growth and traction in other markets. Domestic sales are projected to outpace the broader Indian pharmaceutical market’s 10.1% growth, with the chronic segment showing particular strength. Companies such as Lupin, Sun Pharma, and Cipla are expected to see growth driven by their innovative medicines portfolios and recent launches.
The US market, however, is expected to be a challenge, with overall US sales projected to decline by 4% quarter-on-quarter due to lower Revlimid sales. Excluding Revlimid, US generic sales are forecast to grow by 2% quarter-on-quarter, driven by volume expansion in existing products and the benefits from recent launches. Overall, while the loss of Revlimid patent exclusivity will be a significant challenge for Indian pharmaceutical companies, their domestic growth and innovative medicines portfolios are expected to provide some resilience and drive overall revenue growth.
Stock Market Updates for Zydus Lifesciences
Recent Updates
The Delhi High Court has granted permission to Zydus to market a more affordable biosimilar version of the cancer medication Nivolumab, citing public interest.
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.
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.