Zydus Launches World’s First Nivolumab Biosimilar in India to Cut Cancer Therapy Costs

Indian pharmaceutical company Zydus Lifesciences has rolled out what it is calling the world's first biosimilar of nivolumab, a crucial cancer immunotherapy drug that's been out of reach for most patients due to its steep cost.

The new product, branded Tishtha™, comes in two strengths: a 100 mg vial at ₹28,950 and a 40 mg vial at ₹13,950. That's roughly a quarter of what the original drug costs, which could be a game-changer for the estimated 500,000 cancer patients in India who need this treatment.

The Managing Director of Zydus Lifesciences stated, “At Zydus, we believe every patient deserves timely access to affordable, advanced cancer care. With the launch of Tishtha™, we are expanding access to Immuno-Oncology through a patient-centric therapy.”

What Legal Developments Allowed Zydus to Proceed?

Earlier this month, a Delhi High Court division bench cleared Zydus to sell the biosimilar even before the original patent expires in May 2026. The court held that public interest trumps patent protection for life-saving cancer drugs.

The January 12 ruling overturned an earlier restraint order but told Zydus to keep detailed sales records. If Bristol Myers Squibb (BMS), the company behind the original nivolumab (sold as Opdivo or Opdyta), wins its ongoing patent case, those records will help calculate any compensation owed.

Zydus had already gotten the green light from India's drug regulator, the Central Drugs Standard Control Organisation, after meeting quality and safety benchmarks.

Why This Matters for Cancer Care?

Nivolumab is a monoclonal antibody that helps the immune system spot and destroy cancer cells. It is used to treat lung, kidney, and head and neck cancers, among others. But here is the problem: because it is a complex molecule made from living cells, it has always been expensive.

Doctors have long complained about how pricing puts long-term therapy out of reach for most families. Now, with Tishtha™ priced so much lower, sustained treatment becomes feasible for people who'd otherwise have to stop early.

What Happens Next?

The oncology community will be watching adoption rates closely. There is also the bigger picture for India's pharmaceutical sector: although the country is renowned for producing reasonably priced generics, global corporations have largely retained control over expensive biologics.

If Tishtha™ does well, other Indian firms are likely to enter the biosimilar market with their own products. More competition usually means better access for patients.

Investors are optimistic, too. On the day of the release, Zydus' shares rose 1.09%, signalling confidence in the company's biologics approach. Even if the legal battle over patents continues in the background, this appears to be a significant victory for the cost of cancer treatment for the time being.

Sources:

CNBC

Google Finance

TipRanks

Economic Times