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Difference between generic drugs and biosimilar drugs

Biosimilar drugs and generic drugs are two different things.

Generic drugs contain identical medicinal ingredients to their reference products. They are composed of small molecules that are chemically synthesized.

Biosimilar drugs and their reference biologics are very similar but not identical. This is because biologic drugs:

  • Are often large and complex
  • Are made from living cells rather than with chemicals, making them naturally variable

Compared with the approval process for generic drugs, more studies are needed for the regulatory authorization of a biosimilar drug in order to demonstrate that it is very similar to its reference biologic drug.

If you have any questions about biosimilar drugs, please discuss them with a health care professional.

Last update: September 16, 2021


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