When Will a Pembrolizumab (Keytruda) Biosimilar Reach India?

Merck & Co's Indian patent on pembrolizumab remains valid until June 2028. Until it lapses, a biosimilar cannot be freely manufactured and sold at scale in India. That single date is what holds the price where it is. Merck holds only one valid patent on the molecule itself in India, which is unusually narrow protection for a drug of this size.

A patent date is not a launch date, and the recent Indian history of the other big checkpoint inhibitor shows why. Nivolumab's Indian patent was set to expire on 2 May 2026. Zydus went to court to launch earlier, the Delhi High Court cleared it in January 2026, and the Supreme Court dismissed the originator's plea in February 2026. The biosimilar reached patients before the patent formally lapsed. The same litigation can run the other way and push a launch back. What the Keytruda Patent Expiry Means for Indian Patients goes through the legal position in more detail.

At least seven manufacturers are reported to be working on a pembrolizumab biosimilar for India. The Indian Express reported this in April 2026, drawing on CDSCO expert committee minutes and the Clinical Trials Registry – India. None of the products is approved here. None can be prescribed today.

• Sun, Hetero and Intas Named in April 2026 reporting as among the companies conducting trials or seeking approvals for a pembrolizumab version in India.
• Biocon Said in January 2026 that it would add three more cancer biosimilars to its portfolio, pembrolizumab among them.
• BioThera (China) and Biocad (Russia) Trials of versions developed by these two overseas manufacturers are also underway in India, according to the same reporting.
• At least two further Indian firms The reported count is at least seven; not every developer is publicly named in regulatory minutes or the trials registry.

Nothing in this list compares one manufacturer's product with another's, and being further along in trials is not a statement about quality. A biosimilar is not a copy in the way a generic tablet is a copy: it is a large protein made in living cells, and Indian rules currently require developers to complete animal and late-stage human studies before approval. CDSCO assesses each one against those requirements.

Nobody can price a product that is not yet approved. The honest guide is what happened to other biologics after their Indian protection lapsed. Two precedents are worth knowing, and they point in slightly different directions. The current reference point is that each mandated 200 mg dose of Keytruda was reported in April 2026 to cost more than ₹3 lakh.

The pattern in both cases is the same. The first biosimilar breaks the price. The third and fourth are what make it affordable. Families budgeting around 2028 should plan on a meaningful reduction rather than a collapse in the first year. For what the molecule costs today, and the assistance routes that exist now, see Pembrolizumab (Keytruda) Cost in India.

A patent expiry is a starting gun, not a launch date. Five things stand between June 2028 and a vial a family can actually buy. None of them is unusual, and all of them have delayed a biosimilar in India before.

• Patent clusters Close to a thousand patents and patent families are linked to pembrolizumab worldwide, about 84% of them filed after the drug's 2014 approval. Only one is a valid Indian patent on the molecule, but clusters around a molecule can still be used to challenge biosimilar production after the principal patent expires.
• Litigation The nivolumab case needed the Delhi High Court in January 2026 and the Supreme Court in February 2026 to settle it. A well-resourced originator can take a biosimilar developer to court, and that alone can hold a launch for months.
• Trial requirements Unlike a generic tablet, an Indian biosimilar developer must currently complete animal and late-stage human studies. CDSCO has proposed easing those norms in line with WHO and UK guidance. If that lands, approvals come sooner; if it stalls, they do not.
• Manufacturing capacity Biologics need cell lines, bioreactors and fill-finish capacity that take years to build. The Bio Pharma SHAKTI scheme announced in March 2026, worth ₹10,000 crore, is aimed squarely at that gap, with manufacturers asked to prioritise cancer and autoimmune medicines.
• A shift to new formats Applications for a pre-filled pen and a subcutaneous version of pembrolizumab were reported as filed in India. If prescribing moves to a format that carries its own protection, a biosimilar of the intravenous vial competes with a product that is no longer the standard one.

No. Treatment timing is decided by the cancer, not by a patent calendar. Two years is not medically available waiting time for an active cancer. The question that comes first is not price but whether pembrolizumab is an option for this diagnosis at all — and for most patients in an Indian clinic, it is not.

If it is not indicated for your cancer, June 2028 is not your date and this page can be set aside. If it is indicated, these are the things worth settling now rather than in 2028:

• Confirm the indication in writing Ask which Indian-approved indication your prescription sits under, and what the biomarker result was that supports it. Insurance rejections most often turn on use outside the indication approved in India.
• Ask about the manufacturer's patient access programme It runs through hospital pharmacies and has historically supplied continuing cycles at reduced or no drug cost after a set number of paid cycles, while the patient is still responding.
• Check the scheme ceiling before the first cycle Pembrolizumab is not on India's National List of Essential Medicines, and package ceilings under Ayushman Bharat PM-JAY and Telangana's Aarogyasri were built around chemotherapy costs. Obtain the applicable ceiling in writing.
• Ask what else is approved for your cancer Nivolumab already has a biosimilar in India at roughly a quarter of the reference price. The two medicines are not interchangeable and are approved for overlapping but different indications, so this is a clinical question for your oncologist, not a purchasing one.

One-time grants also exist through the Health Minister's Cancer Patient Fund, the Prime Minister's National Relief Fund and state Chief Minister's Relief Funds. No single route funds an entire course.

Because no legitimate cheaper version exists in India yet. The wait for 2028 is exactly the window counterfeiters work in. An investigation published in April 2026 by the Indian Express with the International Consortium of Investigative Journalists documented a multi-city counterfeit racket in Keytruda in India, with counterfeit vials seized by Delhi Police. A price far below the published range is the single most common feature of a counterfeit offer.

The families targeted are precisely the ones who cannot afford the real thing, which is why this belongs on a page about waiting for a cheaper version. Four protections cost nothing:

• Use only a licensed hospital or hospital-empanelled pharmacy Informal resellers, messaging-group sellers and offers of leftover stock from another patient sit outside every safeguard the supply chain has.
• Insist on a GST invoice with the batch number and expiry Both should match what is printed on the carton. A mismatch is a reason to stop and ask, not to proceed.
• Insist on a documented cold chain The medicine is stored at 2 to 8 degrees Celsius and must never be frozen. A vial delivered warm, frozen, or with no temperature record is unusable regardless of whether it is genuine.
• Report a suspected counterfeit Tell the hospital pharmacy, the manufacturer's verification line and the state drugs controller. Reporting protects the next patient in the queue even when your own vial turns out to be genuine.

Two companion pages go further: Counterfeit Immunotherapy Drugs in India: How to Protect Yourself sets out how the racket operates, and How to Verify an Immunotherapy Vial Is Genuine is a step-by-step check to run before an infusion starts.

This is patient-safety information, not a sales point. Nothing on this page implies where any medicine should be obtained.

For the legal detail behind the June 2028 date, What the Keytruda Patent Expiry Means for Indian Patients is the companion page to this one. For what the medicine costs today and the assistance routes that exist now, see Pembrolizumab (Keytruda) Cost in India. To see how a checkpoint-inhibitor price actually moved once a biosimilar arrived, Nivolumab Cost in India After the Biosimilar Launch has the figures. On safety while the wait continues, read Counterfeit Immunotherapy Drugs in India and How to Verify an Immunotherapy Vial Is Genuine. Every molecule page is indexed at Immunotherapy Medicines Explained, and Immunotherapy covers how this class of treatment works and who it is intended for.

Sources for this page: Indian Express, 7 Indian firms in race, experts eye cheaper Keytruda version in 2 years, 16 April 2026, citing CDSCO expert committee minutes and the Clinical Trials Registry – India; India Today reporting on pembrolizumab access and the June 2028 Indian patent, 13 April 2026; Economic Times Pharma and Business Standard reporting on the Zydus nivolumab biosimilar launch and pricing, 22 January 2026; the Indian Express / International Consortium of Investigative Journalists investigation into counterfeit Keytruda, April 2026; WHO Model List of Essential Medicines, September 2025; CDSCO for Indian approval and marketing status. All prices are indicative and dated. Treatment decisions belong with your treating oncologist.