Dr. Reddy’s Launches Made-in-India Nivolumab Biosimilar NIVORZ Across 12 Cancer Indications

Dr. Reddy’s Laboratories has launched NIVORZ, its indigenously developed and manufactured biosimilar of the cancer immunotherapy nivolumab, in India after receiving approval from the Drugs Controller General of India across 12 cancer indications.

Developed and manufactured entirely in-house at Dr. Reddy’s biologics facility in Bachupally, Hyderabad, NIVORZ marks the company’s entry into biosimilar immuno-oncology in the Indian market. The launch also expands the presence of domestically manufactured biosimilars in a field of cancer treatment where access and treatment costs remain major concerns.

NIVORZ is being supplied as an intravenous medicine in three single-dose vial presentations: 40 mg/4 mL, 100 mg/10 mL and 240 mg/24 mL. The product is a biosimilar of nivolumab, the monoclonal antibody originally developed as an immune-checkpoint inhibitor and widely used internationally in the treatment of several cancers.

Using the Immune System Against Cancer

Nivolumab belongs to a class of cancer medicines known as immune-checkpoint inhibitors. Rather than attacking tumour cells directly in the manner of conventional cytotoxic chemotherapy, the drug works by helping the patient’s immune system recognise and attack cancer cells.

One of the mechanisms used by cancer cells to escape immune surveillance involves the PD-1 pathway. PD-1, or programmed cell death protein 1, is a receptor found on immune cells known as T cells. Under normal circumstances, this pathway plays an important role in preventing excessive immune responses and protecting healthy tissue.

Cancer cells can exploit this regulatory mechanism. By interacting with the PD-1 pathway, tumours can effectively reduce the ability of T cells to recognise and attack them.

Nivolumab is a monoclonal antibody that binds to the PD-1 receptor and blocks this interaction. Removing this inhibitory signal can restore the ability of T cells to mount an immune response against susceptible tumour cells.

This approach has transformed the treatment of several cancers over the past decade and has made PD-1 inhibitors an important component of modern oncology.

Approved Across 12 Cancer Indications

Dr. Reddy’s says NIVORZ has received DCGI approval across 12 indications spanning both solid tumours and haematological malignancies.

The approved uses include treatment settings involving melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma and colorectal cancer.

The approval also extends to specified treatment settings involving oesophageal squamous cell carcinoma, gastric and gastroesophageal junction cancers, malignant pleural mesothelioma and hepatocellular carcinoma.

The exact use of nivolumab varies considerably between cancers. Depending on the disease, stage and previous treatment, it may be administered alone or as part of a combination regimen. Its availability across multiple indications therefore does not mean that the medicine is appropriate for every patient diagnosed with one of these cancers. Treatment remains dependent on oncological assessment and the approved prescribing conditions for the individual indication.

Developed and Manufactured in Hyderabad

One of the most significant aspects of NIVORZ is that Dr. Reddy’s developed and manufactures the biosimilar within its own biologics operations in India.

The medicine is produced at the company’s biologics facility at Bachupally in Hyderabad, giving Dr. Reddy’s control over the product from biological development through manufacturing and eventual commercialisation.

This is considerably more complex than manufacturing a conventional generic medicine.

Traditional generic drugs are generally small molecules with chemical structures that can be reproduced and characterised comparatively straightforwardly. Biologics such as nivolumab are large and structurally complex molecules produced using living biological systems.

A biosimilar therefore cannot simply be treated as an identical chemical copy of the original medicine. Its developer must establish that the product is highly similar to the reference biologic and that any differences do not result in clinically meaningful differences in safety, efficacy or biological activity.

Building this capability requires specialised cell-culture systems, purification processes, analytical technology, manufacturing controls and clinical development infrastructure.

NIVORZ consequently represents not only another pharmaceutical product launch but also the expansion of India’s domestic capabilities in complex biological medicines.

Clinical Programme Included 288 Patients

Dr. Reddy’s evaluated its nivolumab biosimilar through a multinational clinical development programme involving 288 patients.

Of these, 252 participants were enrolled in India and 36 in Russia. According to the company, the programme demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity between its biosimilar and the reference nivolumab product.

Pharmacokinetic comparison examines how a medicine behaves within the body, including its concentration and exposure over time. Immunogenicity assessment is particularly important for biologic medicines because therapeutic proteins can potentially trigger immune responses that may affect their safety or effectiveness.

Establishing comparability across these parameters forms an important part of demonstrating that a biosimilar performs in a clinically comparable manner to its reference biologic.

India’s Biosimilar Capabilities Are Expanding

NIVORZ also builds upon a biologics business that Dr. Reddy’s has been developing for more than two decades.

The company launched what it describes as the world’s first rituximab biosimilar in India in 2007. Its biologics operations have subsequently expanded across oncology and immunology, with products marketed in India and international markets.

Dr. Reddy’s says its biologics capabilities now cover development, manufacturing and commercialisation and extend into areas including biosimilars, novel biologics, cell and gene therapy and contract development and manufacturing.

The significance of this transition extends beyond individual medicines. India built much of its international pharmaceutical position through large-scale production of small-molecule generic drugs. Biosimilars require a substantially different manufacturing and scientific base, involving biotechnology, sophisticated analytical characterisation and tightly controlled biological production processes.

Companies capable of taking biologics from development through clinical evaluation and commercial-scale manufacturing therefore represent a further stage in the evolution of India’s pharmaceutical industry.

NIVORZ Enters an Increasingly Competitive Indian Market

Dr. Reddy’s is not the first Indian pharmaceutical company to introduce a nivolumab biosimilar.

Zydus Lifesciences launched its nivolumab biosimilar Tishtha earlier in 2026, introducing domestic competition into a market previously dominated by the innovator product.

The arrival of NIVORZ creates another Indian-manufactured option in the segment and could increase competition in a category of cancer medicines where treatment affordability remains an important issue.

Dr. Reddy’s estimates that India’s immuno-oncology market was worth approximately ₹3,900 crore in 2025, with medicines including nivolumab, pembrolizumab and toripalimab accounting for a substantial part of the segment.

The company has said that improving access to immunotherapy is one of the objectives behind the launch of NIVORZ. It has not, however, publicly disclosed the commercial price of the medicine, making it premature to quantify the eventual cost difference between NIVORZ and the reference nivolumab product.

Why Biosimilar Competition Matters in Oncology

The development of biosimilars has particular importance in cancer treatment because modern biological therapies can require repeated administration over extended periods.

Unlike conventional generic medicines, biologics are difficult and expensive to develop and manufacture. This has historically limited the number of companies capable of entering the market after the original biological medicine is developed.

Biosimilar competition can broaden the number of available suppliers and potentially improve access, but regulatory approval still requires extensive evidence establishing similarity with the reference product.

For India, domestic development adds another dimension. Manufacturing sophisticated monoclonal antibodies within the country reduces dependence on imported finished biologics while strengthening the biotechnology infrastructure required for increasingly complex medicines.

The same manufacturing and analytical capabilities can subsequently support development of additional biosimilars and potentially novel biological therapies.

A Step Beyond India’s Traditional Generic-Drug Strength

The launch of NIVORZ reflects a broader transformation underway within India’s pharmaceutical industry.

India remains one of the world’s most important producers of generic medicines and active pharmaceutical ingredients, but leading domestic companies are increasingly investing in complex generics, peptides, monoclonal antibodies, biosimilars and other advanced therapies.

These products require considerably greater investment in research, process development, clinical evaluation and specialised manufacturing than conventional generics.

NIVORZ illustrates this transition particularly clearly. The product was developed in India, evaluated through a multinational clinical programme, manufactured at an Indian biologics facility and approved across a broad range of cancer indications.

Its commercial impact will depend on factors including pricing, physician adoption, availability and competition from other nivolumab products. Its industrial significance is already clearer.

An Indian pharmaceutical company has developed an in-house biosimilar of one of the major immune-checkpoint cancer therapies and brought it into domestic commercial production. As India’s pharmaceutical sector moves further into biologics and advanced therapies, capabilities of this kind will become increasingly important to its next phase of growth.

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References

Dr. Reddy’s Laboratories — NIVORZ (Nivolumab Biosimilar) Launch

https://www.drreddys.com

Dr. Reddy’s Laboratories — Biosimilars and Biologics

https://www.drreddys.com/biosimilars

Central Drugs Standard Control Organisation

https://cdsco.gov.in

Economic Times — Dr. Reddy’s Launches Nivolumab Biosimilar in India

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/dr-reddys-launches-nivolumab-biosimilar-in-india/articleshow/134266368.cms

ET Pharma — Dr. Reddy’s Launches Nivolumab Biosimilar NIVORZ

https://pharma.economictimes.indiatimes.com/news/drug-approvals-and-launches/dr-reddys-launches-cancer-blockbuster-nivolumab-biosimilar-in-india/134262279

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