What are biosimilars?

A biosimilar is a biologic medical product that is highly similar to an existing approved branded biologic product, known as the reference product or originator biologic. Biosimilars and their reference products have no clinically meaningful differences in terms of safety, purity, or potency. Biosimilars offer more treatment options and have the potential to reduce healthcare costs, increasing access to lifesaving medicines.

Humira Biosimilar are produced through complex biotechnological processes and cannot be exactly identical to their reference product. However, extensive testing and clinical trials are required to ensure they are as safe and effective. Regulatory bodies like the FDA and EMA have strict guidelines in place to determine biosimilarity.

Major Humira biosimilars approved

Since Humira's patent expired in late 2022, many companies rushed to develop biosimilars. So far, the FDA has approved five Humira biosimilars:

1. Hadlima (Samsung Bioepis): Approved in April 2022.

2. Hyrimoz (Sandoz): Approved in November 2022.

3. Idacio (Pfizer): Approved in September 2022.

4. Hulio (Mylan): Approved in August 2022.

5. Yusimry (Coherus): Approved in January 2023.

The EMA and other regulators worldwide have also approved these five biosimilars. More are expected to enter these markets over the next few years.

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