---
title: "Biosimilars: Definition, Regulation & UPSC Notes"
description: "Biosimilars are biologic medicines closely resembling approved drugs, crucial for affordable healthcare and regulated by guidelines in India and the US."
url: "https://modeldiplomat.com/learn/glossary/biosimilars"
---

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Model Diplomat Research Team · Last reviewed June 22, 2026

TL;DR

- A biosimilar is a biological medicine highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety, purity, or potency.
- How does a biosimilar differ from a generic drug?
- What regulatory pathway governs biosimilars in India?
- What is interchangeability and which jurisdiction uses it?
- Why are biosimilars significant for public health and India?

[Civil Service & Diplomatic Exams](https://modeldiplomat.com/learn/civil-services/glossary)Updated June 22, 2026

A biosimilar is a biological medicine highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety, purity, or potency.

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In 2017 Biocon and Mylan secured US FDA approval for Ogivri, a trastuzumab biosimilar referencing Roche's Herceptin, making it the first biosimilar of the breast-cancer drug cleared in the United States.

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