Which Immunotherapy Medicines Have Indian Biosimilars Today?
As of August 2026, one immune checkpoint inhibitor has an Indian biosimilar: nivolumab. Pembrolizumab, atezolizumab, durvalumab and ipilimumab do not. Several older cancer antibodies that families group under the same word — rituximab, trastuzumab, bevacizumab — have had Indian versions for years. This is the dated list.
Medically reviewed by Dr. T. Raghavender Reddy, Medical Oncologist, MBBS · DM (Medical Oncology) · MD (Radiation Oncology) · Last reviewed August 2026
Which Immunotherapy Medicines Have Indian Biosimilars Today?
Nivolumab, and no other checkpoint inhibitor. One nivolumab biosimilar is marketed in India. Pembrolizumab, atezolizumab, durvalumab and ipilimumab remain originator-only here. Rituximab, trastuzumab and bevacizumab — older cancer antibodies, often called immunotherapy in a family conversation — have had Indian biosimilars for years.
None of these is a "generic". A generic is an identical copy of a small molecule; these medicines are proteins grown in living cells, which no manufacturer can copy exactly. India's term for the copy is similar biologic.
Table 1 — Immune checkpoint inhibitors
| Molecule (class) | Reference brand in India | Indian biosimilar, August 2026 | What is on the public record |
|---|---|---|---|
| Nivolumab (PD-1) | Opdyta | Yes — one product | CDSCO approval reported July 2024; launched January 2026 after the Delhi High Court appeal bench set aside the injunction that had blocked sale |
| Pembrolizumab (PD-1) | Keytruda | No | National media reported in April 2026 that the Indian patent remains in force until June 2028 |
| Atezolizumab (PD-L1) | Tecentriq | No | Originator only; a subcutaneous formulation was launched in India in May 2026 |
| Durvalumab (PD-L1) | Imfinzi | No | Originator only |
| Ipilimumab (CTLA-4) | Yervoy | No | Originator only |
Table 2 — Other cancer antibodies families often call "immunotherapy"
| Molecule (class) | Reference brand | Indian biosimilar, August 2026 | What is on the public record |
|---|---|---|---|
| Rituximab (anti-CD20) | MabThera | Yes — several | India approved the first rituximab biosimilar in 2007; several Indian manufacturers market one now |
| Trastuzumab (anti-HER2) | Herceptin | Yes — several | The first Indian trastuzumab biosimilar was approved in 2013; further entrants followed, including one reported in 2024 |
| Pertuzumab (anti-HER2) | Perjeta | Approved, availability disputed | An Indian biosimilar was launched in June 2024; a Delhi High Court order reported in October 2024 restrained its sale. Confirm current status with the hospital pharmacy |
| Bevacizumab (anti-VEGF) | Avastin | Yes — several | Long-established Indian biosimilars. This is an anti-angiogenic antibody, not an immunotherapy — it is listed only because it is frequently mistaken for one |
Compiled from CDSCO listings, manufacturer announcements, court reporting and national media, reviewed August 2026. This table is refreshed quarterly. Regulatory and litigation positions change; check the review date above before relying on a row. CAR-T and other cell therapies are not biosimilars at all — a living cell product cannot be copied under this pathway — and CION does not provide CAR-T or cell therapy.
Did you know?
The word biosimilar does not appear in India's own rules. The official term is similar biologic, governed by the CDSCO and Department of Biotechnology Guidelines on Similar Biologics. A product sold here as a biosimilar should hold approval under that pathway — and you are entitled to ask which approval it holds.
Which Manufacturers Make Immunotherapy Biosimilars in India?
Zydus Lifesciences markets the only checkpoint inhibitor biosimilar in India, a nivolumab product branded Tishtha. For the older antibodies the field is wider — Dr. Reddy's, Biocon, Glenmark, Hetero and others each market at least one. The names below are matters of public record.
- Nivolumab — Zydus Lifesciences (Tishtha). Approval reported July 2024; launched January 2026. The company described it as the first nivolumab biosimilar launched anywhere.
- Rituximab — Dr. Reddy's (Reditux), and others. Launched in India in 2007 and widely reported as the first monoclonal antibody biosimilar anywhere. Several Indian manufacturers market a rituximab product today.
- Trastuzumab — Biocon (with Mylan), then several more. Approved in India in 2013. Later entrants, including one reported in 2024, changed the price picture more than the first one did.
- Pertuzumab — Zydus (Sigrima), co-marketed with Dr. Reddy's. Launched June 2024; sale restrained by a Delhi High Court order reported in October 2024. Treat availability as unconfirmed until the hospital pharmacy says otherwise.
- Bevacizumab — multiple Indian manufacturers. One of the most crowded biosimilar categories in the country, which is why its price fell furthest.
This page names manufacturers because the names are public and a patient is entitled to know which product is being infused. It makes no comparative quality claim between any of them. Every product listed had to clear the same regulatory pathway.
What Are the Indicative Prices?
Launch reporting in January 2026 put the nivolumab biosimilar at ₹28,950 for a 100 mg vial and ₹13,950 for a 40 mg vial — described as roughly a quarter of the reference price. Pembrolizumab, with no Indian competitor, was reported in April 2026 at figures an order of magnitude higher. All indicative, as of August 2026.
| Product | Published figure | Source and date |
|---|---|---|
| Nivolumab biosimilar, 100 mg vial | ₹28,950 | Manufacturer launch announcement, reported January 2026 |
| Nivolumab biosimilar, 40 mg vial | ₹13,950 | Manufacturer launch announcement, reported January 2026 |
| Nivolumab reference product | Reporting described the biosimilar as about one-fourth the reference price | Trade press, January 2026 |
| Pembrolizumab (originator only) | Reported Indian costs from about ₹50 lakh for a full course to over ₹1 crore a year | National media, April 2026, citing a Tata Memorial Centre analysis |
| Atezolizumab, subcutaneous form | Reported at about ₹3.7 lakh per dose at launch | National media, May 2026 |
| Trastuzumab, per vial, over time | About ₹1.2 lakh before 2012 → about ₹55,000 with the first biosimilar → about ₹15,000 after a 2024 entrant | National media, April 2026, quoting Third World Network |
Every figure above is indicative only, as of August 2026, quoted from published manufacturer announcements or national reporting. None of it is a CION price for any named product. What a family actually pays depends on dose by body weight, cycles planned, hospital, and whether insurance or a state scheme covers that specific brand — ask your treating team for a written estimate for your own plan.
The trastuzumab row is the most useful line here. The first biosimilar halved the price. It collapsed only years later, when several manufacturers were competing. One biosimilar is a discount. Four are a market.
Who this page is not for
This page is not for you if a checkpoint inhibitor has not been raised as an option for your specific cancer, stage and biomarker profile. Immunotherapy is indicated in a defined set of situations, and most cancer patients in India are not candidates for it at all. A cheaper version of a medicine that is not indicated for you is still not indicated for you, and a price list is not a reason to ask for a drug.
Even where the cancer type fits, checkpoint inhibitors need specialist caution or are avoided in active autoimmune disease, ongoing high-dose immunosuppression, after an organ or stem-cell transplant, in pregnancy or breastfeeding, or where performance status is too poor to withstand an immune-related adverse event. The antibodies in Table 2 have their own restrictions — trastuzumab and pertuzumab, for instance, are only for HER2-positive disease and need cardiac monitoring.
And this page is not a price quote, not a recommendation of any named brand or manufacturer over another, and not a way to obtain any of these medicines. There is no route to them outside a prescription, dispensed and infused in a supervised hospital setting.
Why Does Pembrolizumab Still Have No Indian Biosimilar?
Patents, not science. National media reported in April 2026 that the Indian patent on pembrolizumab remains in force until June 2028. Until it lapses, no other manufacturer can market a copy here at scale. Nivolumab reached this point first because its Indian patent position lapsed earlier, in May 2026.
There is a second reason the list moves slowly. Before CDSCO will license one, the maker must run a full comparability programme against a named reference product — analytical characterisation, non-clinical work, a pharmacokinetic study, and a comparative clinical study in a population sensitive enough to reveal a difference. That takes years, so products do not appear the day a patent expires. CDSCO has been reported to be reviewing whether some of those requirements can be eased.
The practical consequence is worth stating plainly. Where a molecule has no Indian competitor, there is nothing to negotiate. Where it does, the size of the saving depends on how many manufacturers are actually selling — not on the first one arriving. For that arithmetic molecule by molecule, see Originator vs Biosimilar: A Price Comparison by Molecule.
Does a Cheaper Indian Biosimilar Mean a Lower Standard?
No. A similar biologic cannot be licensed in India until it has shown no clinically meaningful difference from its reference product in quality, safety, immunogenicity and clinical effect. That is a defined evidence bar set by CDSCO and the Department of Biotechnology. The price gap comes from a shorter development path, domestic manufacture and competition.
What equivalence does not do is predict any individual result. Checkpoint inhibitors help a proportion of patients in the cancers they are indicated for, and that proportion belongs to the molecule and the patient, not to the brand on the vial. Response figures differ by cancer type, line of therapy and biomarker status; NCCN, ESMO and ASCO describe them separately for each approved use. Those numbers should come from your oncologist, against your own biomarker report.
One related question comes up mid-course: whether it is reasonable to move from the originator to a biosimilar part-way through. India has no separate interchangeability designation of the kind the US FDA operates, so it is a prescriber decision, not an automatic pharmacy substitution — see Switching From an Originator to a Biosimilar Mid-Treatment.
How Do You Check the Vial You Are Given Is Genuine?
Have it dispensed and administered by the treating hospital's own pharmacy, and ask to see the vial, the batch number and the invoice. Counterfeit checkpoint inhibitors have been reported entering the Indian market around patent and pricing changes. A wide price gap is exactly the environment in which a fake vial finds a buyer.
This is not a reason to fear the biosimilar. It is a reason to be careful about the supply route. The counterfeit risk attaches to a high-value vial bought outside the hospital chain, whichever brand is printed on it.
- 1
Buy nowhere but the hospital pharmacy
Not through an agent, a relative in another city, a courier, or an online listing — however large the quoted saving. There is no legitimate cheaper channel for a prescription-only biologic.
- 2
Ask which brand, and which approval
The brand name, not just the molecule, belongs in your file. Ask whether it is CDSCO-approved as a similar biologic to the named reference product.
- 3
See the vial before it is opened
Batch number, expiry, manufacturer, intact label and seal. Photograph it if you want a record. This is routine, not an accusation.
- 4
Ask how the cold chain was held, and keep the invoice
These are refrigerated proteins, and a vial that has been warm is not a safe vial — see Why Cold Chain Matters for Immunotherapy Medicines. The invoice for each cycle is your proof of provenance.