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.

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.

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, and healthcare institutions across the country. These tests provide actionable insights into hereditary risk, disease progression, and treatment planning, enabling personalized and evidence-based cancer care.

The MyRisk test helps individuals and families understand genetic cancer risk, enabling informed lifestyle choices and monitoring. The Prolaris and MyChoice HRD Plus tests provide clinically validated insights that guide treatment selection and predict disease progression for patients with prostate and ovarian cancers. With cancer incidence rising worldwide, early identification of inherited risk plays a critical role in prevention and proactive health management.

Dr. Sharvil P Patel, Managing Director of Zydus Lifesciences, stated that the partnership represents a significant step toward improving access to precision diagnostics in India. The tests offer clinicians valuable tools to personalize treatment strategies, assess disease aggressiveness, and streamline clinical decision-making, ultimately helping patients achieve better outcomes. The collaboration reflects Zydus’ continued focus on patient-centric care and precision oncology.

Brian Donnelly, Chief Commercial Officer of Myriad Genetics, emphasized that the collaboration with Zydus will help expand the reach of precision oncology solutions across India. Myriad’s tests are designed to equip clinicians with clear, actionable insights into genetic risk and tumor biology, supporting personalized care and informed treatment decisions. The Prolaris test, in particular, offers a clinically proven method to assess disease aggressiveness and guide treatment choices for prostate cancer patients.

Zydus Lifesciences Limited is an innovation-led life sciences company with a strong presence in pharmaceuticals, consumer wellness, and MedTech. The company operates globally, employing over 29,000 people, including a robust R&D workforce dedicated to advancing healthcare solutions. Myriad Genetics is a global leader in molecular diagnostics and precision medicine, developing tests that assess disease risk, predict progression, and guide treatment decisions across multiple medical specialties. The partnership aims to support earlier and more accurate cancer risk assessment, enabling patients to make informed decisions with greater confidence.

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), human formulations, animal health and veterinary products, as well as health and wellness products.

The company’s product portfolio is categorized into several segments, including India formulations, generics, and Zydus biologics. Some of its notable products include Lipaglyn and Bilypsa (Saroglitazar), which are used to treat various health conditions. Additionally, the company offers a range of biosimilars, such as Ujvira (Trastuzumab emtansine biosimilar), Exemptia (Adalimumab biosimilar), Vivitra (Trastuzumab biosimilar), and Bryxta (Bevacizumab biosimilar), which are used to treat various diseases, including cancer and autoimmune disorders.

Zydus biologics, a key segment of the company, covers a wide range of therapeutic areas, including oncology, autoimmune disease, nephrology, inflammation, rheumatology, hepatology, and infectious illnesses, among others. The company’s products are designed to provide effective treatment options for patients with various health conditions, and its biosimilars are developed to be more affordable and accessible alternatives to traditional biologic therapies.

With a global presence, Zydus Lifesciences Limited markets its products in several key regions, including the United States, India, Europe, and emerging markets. The company’s global reach and diverse product portfolio have established it as a significant player in the global life sciences industry. Through its commitment to innovation and quality, Zydus Lifesciences Limited aims to provide effective and affordable healthcare solutions to patients around the world. Overall, the company’s broad range of products and global presence have positioned it for continued growth and success in the life sciences industry.

A 45-year-old businessman, Himanshu Dineshbhai Shah, has filed a complaint with the Vastrapur police alleging that he was assaulted by an unidentified Activa rider and traffic police personnel during a roadside altercation near the Zydus Bridge last month. The incident occurred on November 12 when Shah was driving with his younger brother towards Gandhinagar. As they stopped at a non-operational traffic signal under the bridge, an Activa rider behind them began honking repeatedly, prompting Shah to move his car aside.

The rider allegedly continued to hurl abuses, and Shah followed him, confronting him and asking why he was using abusive language. The exchange escalated into a physical altercation, and Shah claimed that Traffic Police Constable Chandrasinh Chavda, along with a home guard and Traffic Response Brigade (TRB) personnel, intervened and began beating him with lathis instead of separating the parties involved.

Shah alleged that the officers took him aside, made him sit at their post, and later took all parties into custody after a bystander called the emergency number 100. Shah sought medical treatment the next morning and was admitted to SVP Hospital for 24 hours due to injuries sustained in the incident. On December 9, he submitted a formal written complaint reiterating the events and naming the unknown Activa rider, Constable Chandrasinh Chavda, and other unidentified TRB and home guard personnel.

The Vastrapur police have initiated an inquiry to determine the sequence of events, the conduct of the traffic personnel, and the identity of the Activa rider. The police will take further action based on the findings. Shah’s brother, Ummagbhai Shah, has been listed as a witness in the complaint. The incident has raised questions about the behavior of traffic police personnel and their handling of roadside altercations. The police investigation is ongoing, and it remains to be seen what action will be taken against the accused parties.

The U.S. Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) to Zydus Lifesciences, an injectable facility based in Vadodara, India. The report, which was issued with a Voluntary Action Indicated (VAI) classification, is a result of a Good Manufacturing Practice (GMP) follow-up inspection conducted by the U.S. FDA at the facility from August 25 to September 5, 2025.

The VAI classification indicates that while the FDA has identified certain deficiencies or issues during the inspection, the company is not required to take immediate corrective action. Instead, the company is expected to voluntarily address the identified issues and implement corrective measures to ensure compliance with FDA regulations.

This inspection was a follow-up to a warning letter issued by the U.S. FDA to Zydus Lifesciences on August 29, 2024. The warning letter had highlighted certain deficiencies and violations of FDA regulations, and the recent inspection was conducted to assess the company’s progress in addressing these issues.

The fact that the FDA has issued an EIR with a VAI classification suggests that Zydus Lifesciences has made some progress in addressing the deficiencies identified in the warning letter. However, the company still needs to take further corrective action to ensure full compliance with FDA regulations.

The inspection and subsequent EIR are significant for Zydus Lifesciences, as they highlight the importance of maintaining high standards of quality and compliance in the pharmaceutical industry. The company must now take steps to address the identified issues and implement measures to prevent similar deficiencies from arising in the future.

Overall, the issuance of the EIR with a VAI classification is a positive step for Zydus Lifesciences, as it indicates that the company is on the path to resolving the issues identified by the FDA. However, the company must continue to work towards ensuring full compliance with FDA regulations to maintain its reputation and ensure the quality of its products.

The Taliban-led government in Afghanistan has signed a significant trade agreement with Indian pharmaceutical company Zydus Lifesciences, marking a shift in the country’s trade posture. The $100 million memorandum of understanding was signed between Afghanistan’s Roufi International Group and Zydus Lifesciences in Dubai, in the presence of the Taliban’s ambassador to the UAE. Under the deal, Zydus will export medical products to Afghanistan and is expected to open a local office and begin domestic manufacturing in the country.

This agreement comes after the Taliban imposed a ban on importing pharmaceutical products from neighboring Pakistan, citing concerns over quality and dependency. The Taliban-run Ministry of Finance had given Afghan traders a three-month window to transition to alternative sources, in a move seen as a response to deteriorating political and security ties between Kabul and Islamabad.

The deal with Zydus follows a visit to India by Taliban commerce minister Nooruddin Azizi, who led a delegation to New Delhi at the invitation of the Indian government. This marks a significant development in Afghanistan’s trade relations, as the country seeks to diversify its imports and reduce its dependence on Pakistan.

The agreement is expected to have a positive impact on Afghanistan’s healthcare sector, with Zydus Lifesciences being one of India’s largest publicly listed pharmaceutical firms. The company’s products will help meet the medical needs of the Afghan people, and the establishment of a local office and manufacturing facility will create jobs and stimulate economic growth.

The Taliban’s decision to curtail imports from Pakistan and engage with Indian companies reflects a significant shift in the country’s trade policy. As Afghanistan seeks to rebuild its economy and improve its trade relations, it is likely to explore new partnerships and opportunities with countries like India. The agreement with Zydus Lifesciences is a notable example of this shift, and it remains to be seen how this will impact the country’s trade relations with its neighbors and the wider region.

Zydus, a pharmaceutical company, has introduced a new packaging innovation for its cough medication. The company has launched single-serve pouch packaging for its cough medication, making it more convenient and easy to use for consumers. This new packaging format is designed to provide a single dose of the medication in a compact and portable pouch.

The single-serve pouch packaging is a significant departure from traditional packaging formats, which often require consumers to purchase a larger quantity of medication than they need. This can lead to waste and clutter, as well as make it difficult for consumers to manage their medication regimen. The single-serve pouches, on the other hand, provide a precise dose of medication, reducing waste and making it easier for consumers to take their medication as directed.

The new packaging format is also designed to be more convenient and easy to use on-the-go. The pouches are compact and lightweight, making them easy to carry in a purse, pocket, or backpack. This is particularly useful for consumers who need to take their medication throughout the day, as they can easily toss a pouch into their bag and take it as needed.

In addition to its convenience and portability, the single-serve pouch packaging also provides a number of other benefits. For example, it can help to reduce medication errors, as each pouch contains a precise dose of medication. This can be particularly useful for consumers who have difficulty remembering to take their medication or who have trouble measuring out the correct dose.

The launch of single-serve pouch packaging for cough medication is a significant innovation in the pharmaceutical industry. It reflects a growing trend towards more convenient and patient-centric packaging solutions, and is likely to be welcomed by consumers who are looking for easier and more convenient ways to manage their medication regimen. Overall, the new packaging format is a positive development for consumers and is likely to improve adherence to medication regimens and reduce waste and clutter.

Zydus’s decision to launch single-serve pouch packaging for its cough medication demonstrates the company’s commitment to innovation and customer satisfaction. The company is likely to continue to evolve and improve its packaging solutions in response to changing consumer needs and preferences. As the pharmaceutical industry continues to evolve, it is likely that we will see more companies following Zydus’s lead and introducing innovative packaging solutions that prioritize convenience, portability, and patient-centricity.

Zydus Lifesciences Limited, an Indian pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (USFDA) for its Olaparib Tablets, 100 mg and 150 mg. This medication is used to treat certain types of ovarian, breast, pancreatic, and prostate cancers in patients with specific genetic mutations, specifically in the BRCA gene or other homologous recombination repair (HRR) genes.

The approval is a significant milestone for Zydus, as Olaparib tablets had annual sales of $1,379.4 million in the United States as of September 2025, according to IQVIA data. The tablets will be manufactured at Zydus Lifesciences Ltd’s Special Economic Zone (SEZ) facility. This approval marks a major achievement for the company, which has now received a total of 426 approvals and has filed 487 Abbreviated New Drug Applications (ANDAs) since it began the filing process in 2003-04.

The tentative approval of Olaparib tablets demonstrates Zydus’ commitment to providing high-quality, affordable medications to patients in the United States and globally. The company’s strong research and development capabilities, combined with its state-of-the-art manufacturing facilities, have enabled it to develop and commercialize complex medications like Olaparib.

With this approval, Zydus is well-positioned to capitalize on the growing demand for cancer treatments in the United States and other markets. The company’s portfolio of oncology products, including Olaparib, is expected to drive growth and revenue in the coming years. As a leading pharmaceutical company in India, Zydus is dedicated to improving access to affordable healthcare solutions for patients worldwide, and this approval is a significant step towards achieving that goal. Overall, the tentative approval of Olaparib tablets is a major achievement for Zydus and reflects the company’s commitment to innovation, quality, and patient care.

Zydus Lifesciences, a prominent pharmaceutical company, is facing a significant demand of Rs 74.23 crore from the Goods and Services Tax (GST) authorities. The company plans to challenge this order, indicating a potential dispute over the tax assessment.

The GST demand on Zydus Lifesciences highlights the complexities and challenges that companies face in navigating the tax landscape in India. The pharmaceutical industry, in particular, has been subject to various regulatory and tax changes, which can impact their operations and financial performance.

Zydus Lifesciences is a leading player in the Indian pharmaceutical sector, known for its innovative products and research-driven approach. The company has a strong presence in the domestic market and exports its products to various countries worldwide.

The GST demand on Zydus Lifesciences is likely to be contested by the company, and the outcome of this dispute will be closely watched by the industry and tax experts. The company’s decision to challenge the order suggests that it believes the tax assessment is incorrect or unjustified.

The development comes at a time when the Indian government is actively working to simplify and streamline the tax system, including the GST regime. The government has introduced various measures to reduce compliance burdens and improve the overall business environment.

In this context, the dispute between Zydus Lifesciences and the GST authorities underscores the need for clarity and consistency in tax laws and regulations. The outcome of this case will have implications not only for the company but also for the broader pharmaceutical industry, which is a significant contributor to India’s economy.

As the case progresses, it will be interesting to see how the company and the tax authorities navigate the complex issues involved. The dispute highlights the importance of effective tax management and compliance for businesses operating in India, particularly in regulated sectors like pharmaceuticals.

Overall, the GST demand on Zydus Lifesciences is a significant development that will be closely monitored by the industry, tax experts, and regulatory authorities. The outcome of this dispute will have implications for the company, the pharmaceutical sector, and the broader business environment in India.

Zydus Lifesciences, a pharmaceutical company, has been instructed to revise a post-marketing surveillance (PMS) study for its Tofacitinib ER (extended-release) tablets. The company had submitted the study protocol to the regulatory authorities, but it appears that the submission did not meet the required standards.

Tofacitinib is a medication used to treat various inflammatory conditions, including rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis. The extended-release formulation of the tablets allows for once-daily dosing, which can improve patient compliance. However, as with any new drug or formulation, regulatory authorities require thorough evaluation of its safety and efficacy in real-world settings through PMS studies.

The revision of the PMS study protocol is crucial for several reasons. Firstly, it ensures that the study design is robust enough to capture accurate and reliable data on the safety and efficacy of Tofacitinib ER tablets in a large and diverse patient population. Secondly, the revised protocol must address any concerns or gaps identified by the regulatory authorities, which could include issues related to patient selection, data collection methods, and analytical approaches.

The requirement for revision may also indicate that the initial protocol did not fully adhere to regulatory guidelines or did not provide sufficient detail on how the study would handle potential challenges, such as patient dropout rates or the management of adverse events. The regulatory authorities’ feedback is an essential part of the drug development and approval process, ensuring that pharmaceutical companies conduct rigorous and meaningful research to support the safe and effective use of their products.

In response to the regulatory feedback, Zydus Lifesciences will need to revise and resubmit the PMS study protocol. This process involves addressing the specific concerns and recommendations provided by the regulatory authorities, which could require adjustments to the study design, methodology, or even the inclusion and exclusion criteria for patients. Once the revised protocol is approved, the company can proceed with conducting the PMS study, which will provide critical insights into the real-world performance of Tofacitinib ER tablets.

The outcome of the PMS study will be significant, not only for Zydus Lifesciences but also for patients and healthcare providers. It will contribute valuable information to the body of evidence supporting the use of Tofacitinib ER tablets, helping to optimize treatment strategies and improve patient outcomes. Through this process, regulatory authorities ensure that pharmaceutical companies maintain high standards of research and drug development, ultimately protecting public health and advancing medical science.