Indian Court Dismisses Zydus Trastuzumab Lawsuit, Citing Lack Of Genuine Claim.
In a significant development, the Bombay High Court has dismissed a pre-emptive lawsuit filed by Indian pharmaceutical company Zydus Cadila against Swiss multinational company Roche nearly a decade ago. The lawsuit related to Zydus Cadila’s biosimilar version of Roche’s blockbuster cancer drug Herceptin. The court’s decision brings an end to a long-drawn-out legal battle that had been plagued by procedural delays.
Zydus Cadila had filed the pre-emptive complaint in an attempt to stave off potential litigation from Roche over its biosimilar Herceptin. However, the Bombay High Court has now ruled that Zydus Cadila’s complaint was an “illusion” of a real dispute, implying that there was no genuine controversy between the two parties. This decision suggests that Zydus Cadila’s lawsuit was premature and lacked substance.
The dispute centered around Zydus Cadila’s development of a biosimilar version of Herceptin, which is a monoclonal antibody used to treat certain types of breast cancer. Roche had been selling Herceptin globally, including in India, and had been seeking to protect its patent and intellectual property rights. Zydus Cadila, on the other hand, had been trying to launch its biosimilar version of the drug in the Indian market.
By filing the pre-emptive complaint, Zydus Cadila had hoped to gain a strategic advantage over Roche. However, the court’s decision has now dismissed this lawsuit, paving the way for Roche to potentially take action against Zydus Cadila’s biosimilar Herceptin. This could lead to further litigation between the two companies, with Roche seeking to protect its intellectual property rights and Zydus Cadila fighting to launching its biosimilar product.
The Indian pharmaceutical industry has been witnessing a surge in the development of biosimilars, which are cheaper versions of biologic drugs. The court’s decision in this case is likely to have significant implications for the industry, as it sets a precedent for how pre-emptive lawsuits will be treated in the future. The decision also highlights the complexities and challenges involved in intellectual property disputes in the pharmaceutical sector, particularly in the context of biosimilars.
Authorities with the DCA have seized counterfeit Levipil 500 tablets.
The Telangana State Drugs Control Administration (DCA) has cracked down on counterfeit medication in the region, seizing fake Levipil 500 tablets, which are used to treat epilepsy. The tablets were falsely labeled as products of Sun Pharma Laboratories Ltd, a reputable pharmaceutical company. The DCA’s special teams conducted raids at two locations: Arvind Pharma Distributors in Kavadiguda and Venu Medical Agencies in Karimnagar, where the counterfeit tablets were being distributed.
The raids took place on July 4 and 5, 2025, and the DCA was able to confirm the counterfeit status of the tablets by cross-checking them with Sun Pharma’s official records. The seizure of these fake tablets is a significant achievement for the DCA, as it helps to protect the public from the dangers of counterfeit medication. Counterfeit drugs can be ineffective, toxic, or even fatal, and it is essential to ensure that all medication is genuine and safe for consumption.
The DCA is now investigating the sources of the counterfeit tablets and will take legal action against those involved. The administration is also urging the public to report any suspicious drug production activities, including those involving narcotics and psychotropic substances, in any area. To facilitate this, the DCA has set up a toll-free number, 1800-599-6969, which is available from 10:30 am to 5 pm on weekdays. Citizens can use this number to report any illegal drug activities, and the DCA will take prompt action to address the issue.
The DCA’s efforts to combat counterfeit medication are crucial in ensuring the safety and well-being of the public. The administration’s actions demonstrate its commitment to protecting the health and welfare of the people of Telangana, and its efforts will help to prevent the spread of counterfeit medication in the region. By reporting suspicious activities and working together, the public and the DCA can help to create a safer and healthier environment for everyone.
Lupin Splits Off Its Consumer Healthcare Business to Form Independent Company
Lupin, a leading pharmaceutical company, has created a new subsidiary called LupinLife Consumer Healthcare Ltd to house its consumer healthcare business. This move is in line with a growing trend among pharmaceutical companies, both in India and globally, to separate their consumer health operations from their prescription drug businesses. The goal is to better target the rapidly expanding self-care market in India. Anil Kaushal will lead the new subsidiary as CEO, bringing strategic focus and agility to Lupin’s consumer health portfolio.
The separation of the consumer healthcare business from the prescription drug business allows for more targeted investments and a dedicated approach to building strong consumer brands in the over-the-counter (OTC) space. Lupin’s OTC consumer healthcare business contributed ₹148 crore to the company’s total standalone revenue of ₹14,666 crore in FY24. The new subsidiary has a strong portfolio of scientifically formulated brands, including Softovac, Beplex Forte, Corcium, and Aptivate, which are positioned to leverage the rising demand for preventive healthcare and wellness in India.
The pharmaceutical sector is witnessing a trend of spinning off consumer health units, as companies recognize the need for separate business models to cater to prescription drugs and OTC healthcare products. This allows companies to streamline operations and adopt more FMCG-style promotion strategies tailored for consumer health products, while maintaining focus on their traditional pharma businesses. Companies such as Cipla, Glenmark, Mankind Pharma, and Sanofi have already adopted similar strategies.
The formation of LupinLife Consumer Healthcare Ltd reflects the company’s long-term vision of adapting to evolving healthcare needs and market dynamics in India. With this move, Lupin joins a broader industry shift that seeks to unlock value and accelerate growth in two distinct but complementary healthcare markets – prescription pharmaceuticals and consumer wellness products. The company’s move is expected to enable it to sharpen its focus on prescription drugs while allowing the OTC arm to thrive independently in a fast-growing and competitive consumer healthcare market.
Piramal Pharma Solutions initiates a $90 million expansion project in the United States.
Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organisation (CDMO), has announced a $90 million investment plan to expand two of its US facilities. The expansion is aimed at enhancing the company’s integrated offering, particularly in the area of antibody-drug conjugate (ADC) therapies. The two sites involved in the expansion are located in Riverview, Michigan, and Lexington, Kentucky.
The Riverview site provides comprehensive drug substance development and manufacturing services, including specialized solutions for high potency APIs (HPAPIs). The expansion at this site will add a commercial-scale suite for the development and manufacturing of payload-linkers, which are essential components of ADC therapies. The new suite is expected to be operational by the end of 2025.
The Lexington site is Piramal Pharma’s dedicated fill/finish facility, specializing in sterile compounding, liquid filling, and lyophilization for sterile injectable drug products. The expansion at this site will add commercial-scale sterile injectable manufacturing capabilities, including 24,000 additional square feet of manufacturing space, a new laboratory, and state-of-the-art machinery. The expansion is expected to be completed by late 2027.
The investment is driven by the growing demand for sterile injectables, which is projected to exceed $20 billion by 2028. Piramal Pharma’s Chairperson, Nandini Piramal, expressed confidence that the expansion will enable the company to meet the demands of this market and reinforce its position as a trusted global partner in biologic manufacturing. The expansion is expected to enhance the services provided to partners, ultimately reducing the burden of disease for more patients around the globe.
The expansion is a strategic move by Piramal Pharma to strengthen its presence in the biologic manufacturing market. The company’s ADCelerate platform, which provides integrated services for ADC therapies, is expected to benefit from the expansion. The new facilities will provide Piramal Pharma with the capacity to develop and manufacture complex biologic products, including ADCs, and will enable the company to support its partners in bringing new therapies to market. Overall, the investment is a significant step forward for Piramal Pharma and is expected to have a positive impact on the company’s growth and reputation in the industry.
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