Which Checkpoint Inhibitors Are Approved in India?

Several checkpoint inhibitors are approved and marketed in India. Pembrolizumab, nivolumab, atezolizumab and durvalumab are the ones most commonly named on Indian prescriptions, with ipilimumab used in combination and toripalimab launched more recently. Each is approved for specific cancers and treatment lines, not for cancer generally. Nivolumab now also has an Indian biosimilar.

Medically reviewed by Dr. Bharati Devi Gorantla, Medical Oncologist, MBBS · MD · DM (Adyar, Chennai) · ECMO · MRCP SCE (UK) · Last reviewed August 2026

Six checkpoint inhibitor molecules account for almost all checkpoint inhibitor use in India: pembrolizumab, nivolumab, atezolizumab, durvalumab, ipilimumab and toripalimab. Four of those — pembrolizumab, nivolumab, atezolizumab and durvalumab — are the ones patients see most often. Approval is granted indication by indication, never for a molecule as a whole.

Most people arrive at this question holding a prescription, not a drug class. The name printed on a day-care chart is usually a brand — Keytruda, Opdyta, Tishtha, Tecentriq, Imfinzi, Zytorvi — while the molecule that decides everything clinically is the longer word ending in -mab beside it. The table below is the master reference for this section, built so both names, the class, the usual cancers and the Indian version status can be read in a single view instead of being pieced together across separate drug pages.

One point matters before the table: appearing on this list does not mean a medicine is suitable for you, and it does not mean CION or any other centre holds stock of it. This page describes medicines that exist in the Indian market. It does not offer them.

Sources: reported product launches and regulatory reporting up to August 2026, including Dr. Reddy's Laboratories' toripalimab launch announcement (November 2024) and reporting on the Zydus nivolumab biosimilar launch (January 2026). Cancer associations follow broadly published NCCN, ASCO and ESMO patient-education patterns and are not an India-specific indication list.

Approved uses cluster around a defined set of cancers. Lung cancer, melanoma and other skin cancers, kidney cancer, bladder cancer, head and neck cancers, liver and biliary cancers, and nasopharyngeal carcinoma account for most checkpoint inhibitor use in India. A separate route qualifies tumours on biomarker grounds rather than organ of origin.

That biomarker route matters because it cuts across the organ-based list. Where a tumour is microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR), checkpoint inhibitor treatment may be considered in cancers that would not otherwise appear on the list at all. PD-L1 expression, reported as a Tumour Proportion Score (TPS) or a Combined Positive Score (CPS) depending on the cancer, works the other way — it usually decides whether a checkpoint inhibitor is considered first-line, in combination with chemotherapy, or only later in treatment.

Approval also carries a line and a stage inside it. Durvalumab, for example, is best known in stage 3 lung cancer as consolidation after chemoradiotherapy rather than as a first treatment. Ipilimumab is rarely used alone. Toripalimab's Indian approval is narrow and specific to nasopharyngeal carcinoma. Two medicines in the same class can therefore sit at completely different points in a treatment plan for the same patient.

The honest summary is that a cancer appearing in the table above tells you a checkpoint inhibitor is possible in that disease, in some patients, at some point. It does not tell you that it applies to a particular person. Most Indian patients with these cancers are not candidates for checkpoint inhibitor treatment, and being told so is not a lesser standard of care.

Nivolumab is the one with a domestic Indian version. Zydus Lifesciences launched Tishtha, an Indian biosimilar of nivolumab, in January 2026 after a Delhi High Court division bench permitted its sale ahead of the originator patent's expiry on 2 May 2026. Toripalimab is manufactured and marketed in India by Dr. Reddy's, though as an in-licensed product rather than a biosimilar.

A biosimilar is not a generic. Nivolumab is a large, complex antibody rather than a simple chemical, so a biosimilar has to prove through its own analytical and clinical studies that there is no clinically meaningful difference from the reference product before a regulator will approve it. Once approved, oncologists treat it as clinically equivalent within its approved indications — not as a cheaper compromise.

The cost gap is the reason this matters to families. At launch in January 2026, Tishtha was reported at ₹13,950 for a 40 mg dose and ₹28,950 for a 100 mg dose, against a reported originator range running from roughly ₹21,500 to over ₹1,00,000 across different dose sizes. Those are reported published figures, indicative only, as of August 2026 — they are not a CION price, and the amount any family actually pays depends on dose, cycle count, hospital and insurance or scheme coverage.

Pembrolizumab, atezolizumab and durvalumab had no marketed Indian biosimilar at the time this page was reviewed. Pembrolizumab's patent protection has been reported as beginning to lapse around 2028-29, which is the earliest point at which Indian versions of that molecule would become possible. Nothing about a biosimilar's arrival changes who is eligible for the treatment — it changes what the treatment costs, not who benefits from it.

Who this list is not for

Checkpoint inhibitors are not for most patients with cancer in India, and this page is not a way of finding out whether you are one of the few for whom they are considered. Eligibility is decided on cancer type, stage, prior treatment, organ function and, for many indications, a biomarker result — not on a molecule appearing in a table.

These medicines are specifically not used, or used only with great caution, in people with an active autoimmune condition, in people on long-term immunosuppressive medicines including higher-dose steroids, in patients whose performance status is too poor to tolerate an immune-related side effect, and in several other situations that only a treating oncologist can assess against your own reports. Prior organ transplantation is another setting where the risks change substantially.

This page is also not: a way to select your own medicine; a price quote for treatment; a complete or India-specific label reference for every indication of every molecule; a statement that CION stocks, supplies or dispenses any medicine named here; or a guide to paediatric, off-label or clinical-trial use, none of which it covers. If you want to know whether any medicine on this page applies to your diagnosis, that conversation belongs with your treating oncology team.

No. The table lists the molecules whose Indian position could be established at the time of review. Several checkpoint inhibitors approved elsewhere — cemiplimab, avelumab, dostarlimab and a number of newer PD-1 agents among them — have an Indian approval and marketing status that could not be confirmed here.

Stating that those medicines are unavailable in India would be as inaccurate as stating that they are available, so this page says neither. Regulatory status in India moves indication by indication and month by month, and a molecule can be approved without being actively marketed, or marketed for a narrower set of uses than its global label. Named-patient import is also possible in specific circumstances for some products. Where an oncologist raises a medicine that is not in the table above, the absence is a limit of this page, not evidence about the medicine.

If you want to check a specific product, the treating hospital's pharmacy is the practical place to ask, and the CDSCO's own approval listings are the authoritative published record. Neither this page nor any patient-education page should be the last word on whether a medicine can be obtained.

Look for two names on the prescription or day-care chart. The brand name is usually printed larger. The molecule name sits alongside or beneath it and ends in -mab. The molecule is what matters clinically; the brand only tells you whose version is being used.

• Keytruda → pembrolizumab, an anti-PD-1 medicine.
• Opdyta or Tishtha → nivolumab, an anti-PD-1 medicine. Two brands, one molecule, and the difference between them is manufacturer and price, not treatment.
• Tecentriq → atezolizumab, an anti-PD-L1 medicine.
• Imfinzi → durvalumab, an anti-PD-L1 medicine.
• Yervoy → ipilimumab, an anti-CTLA-4 medicine, usually given with a PD-1 inhibitor rather than alone.
• Zytorvi → toripalimab, an anti-PD-1 medicine used in nasopharyngeal carcinoma.

Because checkpoint inhibitors are high-value, cold-chain biologics, counterfeit product has been reported entering the Indian market around patent and exclusivity changes. That is a genuine patient-safety issue rather than a scare. Asking the treating hospital how a vial's authenticity and cold-chain storage were verified is a fair question, not a challenge to your care team, and any well-run day-care unit will have an answer.

Checkpoint inhibitors are given as day-care infusions, so the chart in front of you during the infusion is usually the clearest record of what is being administered. If the two names on it do not match anything in the table above, ask for the molecule name to be written out — that single word is what every other page on this site, and every guideline document, is organised around.

No. Approval means a regulator accepted the evidence for a medicine in a defined population, stage and line of treatment. It says nothing about whether an individual patient falls inside that population. Approval is the outer boundary of what may be considered, not a recommendation for anyone.

Two further points get lost in the gap between an approval list and a real treatment plan. The first is that response to checkpoint inhibitors varies widely between patients and between cancers, and published response-rate ranges from bodies such as NCCN, ASCO and ESMO describe trial populations rather than predicting any one person's outcome. The second is that immune-related side effects are a real part of the trade-off — a settled reason why some patients who are technically eligible are still advised against treatment. Those reactions are described in detail on the individual molecule pages, including nivolumab side effects, and across the wider immunotherapy section.

If a checkpoint inhibitor has been suggested to you, the useful questions are which indication and line you fall into, what biomarker testing was done, what the alternative would be, and what the expected side-effect burden looks like for your situation. Those are questions for your treating oncologist, and a second opinion on the reasoning is always reasonable to seek.

This page is the index. Each molecule in the table has its own page covering approved uses, published cost context and the side-effect picture in far more detail than a reference table can hold.

• Nivolumab Side Effects — the safety picture for the one molecule on this list that now has an Indian biosimilar, and the side effects that apply to both brands equally.
• Atezolizumab (Tecentriq): Uses, Cost and Side Effects — the anti-PD-L1 medicine most often seen in lung and liver cancer treatment plans.
• Durvalumab (Imfinzi): Uses, Cost and Side Effects — why this one usually appears after chemoradiotherapy in stage 3 lung cancer rather than as a first treatment.
• Immunotherapy Medicines Explained — the full medicines section this table indexes, including brand-versus-biosimilar comparisons and how the cost information here is sourced.

This page is an editorial reference for patient education. It does not claim that any named checkpoint inhibitor is superior to another, does not state that CION stocks, supplies or dispenses any medicine named here, and carries no CION price against any molecule. Pricing figures are reported published figures, indicative only, as of August 2026. Approval status reflects the position established at the time of review and should be confirmed with your treating oncologist, the hospital pharmacy, or the current CDSCO record before being relied on.