Biosimilars: — Quality, Regulation and Price

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.

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.

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.

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.

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.

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.