Zydus Lifesciences Ltd on Friday announced the completion of a US Food and Drug Administration (USFDA) inspection at its Unit-2 manufacturing facility in Ankleshwar, Gujarat. The regulatory review, conducted from 19 to 23 January, 2026, concluded with three observations, with the company noting that none were related to data integrity concerns.

USFDA Inspection Results

The pharmaceutical company stated it will collaborate closely with the USFDA to address the identified observations promptly. The completion of the inspection represents a routine regulatory milestone for the manufacturing facility.

Launch of Cancer Biosimilar

In a separate announcement, Zydus introduced Tishtha™, positioned as the world's first biosimilar of Nivolumab, a cancer immunotherapy drug. The treatment addresses multiple cancer types and will be available in the Indian market at approximately one-fourth the cost of the reference drug.

The biosimilar will be offered in two dosage options to optimize treatment protocols:

This pricing strategy aims to enable oncologists to optimize dosing while minimizing drug wastage, potentially improving access to advanced oncology treatments across India.

Acquisition Speculation

Regarding media reports about potential acquisition discussions with US biopharmaceutical company Ardelyx, Zydus declined to provide commentary on business development activities. Sources had indicated on 20 January that the company might pursue either a controlling stake acquisition or selective molecule purchases as part of a proposed transaction.

Market Performance

Shares of Zydus Lifesciences Ltd closed trading on Friday, January 23, at ₹883.00 on the NSE, representing a decline of 0.26% for the session.

Zydus Lifesciences has achieved a significant milestone in cancer care by launching Tishta™, the world's first biosimilar nivolumab, in the Indian market. This groundbreaking development represents a major advancement in making advanced cancer therapies more accessible to patients across the country.

Product Launch and Pricing Strategy

The company has strategically positioned Tishta™ as an affordable alternative to existing cancer treatments. The biosimilar is available at two price points, offering flexibility for different treatment requirements and patient needs.

Market Impact and Accessibility

By pricing Tishta™ at roughly 25% of the original drug's cost, Zydus Lifesciences has created a substantial cost advantage for cancer patients. This significant price reduction is expected to make advanced cancer treatment accessible to a broader patient population who previously could not afford such therapies.

The company's ambitious target of helping over 500,000 patients demonstrates the scale of impact this launch could have on India's cancer care landscape. This patient reach represents a substantial expansion in access to nivolumab-based treatments.

Therapeutic Applications

Tishta™ has been developed for treating various types of cancers, expanding treatment options for oncologists and patients. As a biosimilar nivolumab, it offers the same therapeutic benefits as the original drug while maintaining the quality and efficacy standards required for cancer treatment.

Strategic Significance

This launch positions Zydus Lifesciences as a pioneer in biosimilar development, particularly in the oncology segment. Being the world's first biosimilar nivolumab represents a significant achievement in pharmaceutical innovation and could establish the company as a leader in affordable cancer care solutions.

The introduction of Tishta™ reflects the growing importance of biosimilars in making expensive biological drugs more accessible, particularly in emerging markets where cost considerations play a crucial role in treatment decisions.