What Are Biosimilars? – HealthyWomen

What is a biosimilar?

Biosimilars are medicines made from living material, such as bacteria or plant cells. They follow the model of another type of drug called biological that is also made from living material.

Why do people use biosimilars?

Biosimilars can be used to treat a variety of health problems, including:

  • Chronic skin diseases, such as psoriasis.

  • Chronic intestinal disease

  • Diabetes

  • Arthritis

  • Certain kidney conditions

  • Multiple sclerosis

  • Macular degeneration

  • Certain cancers

Biosimilars are:

As safe as biological ones

As effective as biological ones

Less expensive than organic

How does a biosimilar get FDA approval?

By demonstrating that it works in exactly the same way as the reference product.

Are biosimilars the same as generic drugs?

They are similar but not the same.

Generics, made from chemicals, are exactly the same as brand-name drugs.

Biosimilars, made from living materials, are very similar to the reference product.

Why aren’t they exactly the same?

Both biologics and biosimilars are made from living materials, so both have some variability.


Some biosimilars are interchangeable with their reference products.

This means that you do not need a new prescription to replace the biological with the biosimilar.

(Biosimilars that are not interchangeable require a new prescription.)

Are biosimilars an option for you? Ask your healthcare provider.

This resource was created with the support of Sandoz, a member of HealthyWomen’s Corporate Advisory Board.

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