India published biosimilar-specific regulatory guidelines in 2012 and updated them in 2016 — placing it among the earlier countries to have a dedicated framework for approving these medicines.
Biosimilars: — Quality, Regulation and Price
You may have been told your treatment uses a biosimilar, or that one is available at a much lower cost. A biosimilar is not a cut-price substitute. It is a different manufacturer's version of the same biological medicine, approved through a specific regulatory process before it can be used.
- Not a generic — Biosimilars are biological medicines. They cannot be chemically identical copies — they are approved as highly similar through rigorous head-to-head testing.
- CDSCO-approved — Every biosimilar on the Indian market has passed a specific regulatory review before approval. The price gap does not reflect a quality gap.
- Same active molecule — The active molecule — trastuzumab, rituximab, bevacizumab — is the same as in the originator. The lower price comes from lower development costs, not lower quality.
- Your oncologist decides — Whether you receive the originator or a biosimilar, and whether to switch during treatment, is a clinical decision made for your individual case.
Medically reviewed by Dr. Naresh Gundu, Medical Oncologist, MBBS (Chalmeda Anand Rao Institute of Medical Sciences, Karimnagar) · DNB Internal Medicine (Sir Gangaram Hospital, New Delhi) · DM Medical Oncology (AIIMS) · Last reviewed September 2026
A biosimilar is a biological cancer medicine approved by CDSCO as highly similar to an already-licensed original. It is not a generic — biological medicines are too complex to copy exactly — but it must pass comparability testing to the same quality and safety standards. The price is typically substantially lower than the branded originator.
How is a biosimilar different from the original branded medicine?
| Branded biologic (originator) | CDSCO-approved biosimilar | |
|---|---|---|
| Active molecule | The original — e.g. trastuzumab, rituximab, bevacizumab | The same molecule, produced by a different manufacturer |
| Regulatory pathway | Full clinical development programme; CDSCO licence after Phase I–III trials | Abbreviated pathway under CDSCO's biosimilar guidelines: comparability data and clinical bridging studies |
| Testing required before approval | Large, long-term original trials across many patients | Comparability exercise demonstrating no clinically meaningful difference from the originator |
| Quality standards | Good Manufacturing Practice (GMP); tested for potency, purity and identity | Same GMP requirements; tested for equivalence in structure, biological activity and safety profile |
| Interchangeability during treatment | The reference medicine against which biosimilars are compared | Not substituted automatically — switching is a clinical decision your oncologist makes for your case |
| Indicative price in India (2024–25) | Higher; the originator price has historically been a significant access barrier | Substantially lower; published market data show a several-fold difference for the same molecule and vial size |
Does a lower price mean lower quality?
No. The price difference does not reflect a quality difference. It reflects the difference in development costs: the originator company spent decades and large sums on original clinical trials, and the biosimilar manufacturer did not have to repeat that investment.
CDSCO requires biosimilar manufacturers to demonstrate comparability — that their product behaves in the same way as the originator in laboratory testing, preclinical studies and clinical bridging data. A lower price is the expected consequence of a different development pathway, not a warning sign.
Biological medicines are made in living cells, which means no two batches of any biologic — including the originator — are perfectly identical. This is why the regulatory term is 'highly similar' rather than 'identical'. That variability exists across production runs of the originator too, and regulators account for it.
Who these medicines are not for
These biological medicines are not suitable for everyone. Each has specific restrictions based on tumour biology, organ function and medical history.
- Trastuzumab is not given to patients whose tumour does not express the HER2 protein. It is also withheld or used with caution in patients with significantly reduced heart function.
- Rituximab is not given where the tumour does not express the CD20 marker.
- Bevacizumab is not given to patients with uncontrolled high blood pressure, recent major surgery, serious bleeding, or certain types of lung involvement.
- Any of these medicines may be withheld during pregnancy or in patients with severe hypersensitivity to the molecule or any of its components.
This list is not complete. Eligibility is decided by an oncologist on the individual case, based on test results, current health and the full treatment plan.
What do terms like biosimilar, biologic and originator actually mean?
- Biologic (biological medicine)
- A medicine made in living cells — a yeast, bacterium or mammalian cell — rather than by chemical synthesis. Because of how they are made, biologics are large, complex molecules that cannot be copied exactly the way a small chemical drug can.
- Biosimilar
- A biological medicine approved by a regulatory authority as highly similar to an already-approved original. It uses the same active molecule and must pass specific testing to show no clinically meaningful difference from the originator.
- Originator (reference medicine)
- The original biological medicine licenced first, on the basis of full clinical trials. The biosimilar is compared against this product during its own approval process.
- Comparability exercise
- The structured head-to-head testing a biosimilar must pass — comparing its structure, biological activity and safety profile against the originator — before CDSCO will approve it.
- CDSCO
- The Central Drugs Standard Control Organisation, India's national drug regulator. It reviews and approves both originators and biosimilars, and published specific biosimilar guidelines in 2012, updated in 2016.
Did you know?
Every biosimilar approved by CDSCO must complete a staged comparability exercise covering analytical, preclinical and clinical data. Approval on the basis of price or manufacturing cost alone is not permitted under these guidelines.
Source: CDSCO Guidelines on Similar Biologics (Biosimilars), 2016; WHO Guidelines on Evaluation of Similar Biotherapeutic Products, 2009
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Frequently asked questions
Is a biosimilar exactly the same as the original medicine?
No, and this is one of the most important things to understand. Biological medicines are made in living cells, which means even two batches of the originator are not perfectly identical. Because of this complexity, a biosimilar is approved as 'highly similar' rather than 'identical'. It has been tested head-to-head against the originator to show that any differences are not clinically meaningful. The regulatory standard is comparability, not chemical identity.
Why is the price difference so large?
The originator company funded the original clinical trials — which can take a decade or more and cost a very large sum — and the originator price reflects that investment. A biosimilar manufacturer competes using comparability data rather than a full original development programme, so the development cost is substantially lower and this is passed through in the price. The large price gap is the intended consequence of biosimilar regulation, not a sign that the medicines are different in quality.
Will my oncologist tell me if I am being given a biosimilar?
Yes, and you have the right to ask. Your treatment consent and drug administration record should reflect which product you are receiving. If you have been told you are getting trastuzumab, rituximab or bevacizumab and you are not sure whether it is the originator or a biosimilar, ask your treating team directly. They will tell you which product is being used and can explain the basis for that decision in your case.
Can I switch between a biosimilar and the original during treatment?
Switching is a clinical decision your oncologist makes based on your case — it is not something that happens automatically or without discussion. Current guidance from bodies including WHO and ESMO acknowledges that switching is practised in many settings, and that evidence for routine interchangeability continues to develop. Your oncologist will weigh the clinical and practical factors in your specific situation. If you are concerned about a proposed switch, ask your team to explain the reasoning.
Are trastuzumab, rituximab and bevacizumab biosimilars approved in India?
Yes. CDSCO-approved biosimilars of these three molecules are available and in routine clinical use in India, in both public and private oncology settings. Each went through the CDSCO biosimilar approval process before reaching the market. Biosimilars of these molecules have also been approved by the EMA and US FDA, meaning the comparability data have been reviewed by multiple major regulatory authorities, not only CDSCO.
What should I ask my oncologist about biosimilars?
Ask three things: whether the treatment you have been prescribed is an originator or a biosimilar; what that choice is based on in your case; and what would happen if you wanted to switch at any point. You might also ask whether the choice affects your monitoring schedule. Understanding the basis for the decision is reasonable to expect, and a clear answer to these questions is something your team should be able to give you.
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