What Are Biologics and Biosimilars?

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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You may be unfamiliar with the terms biologics or biosimilars but if you watch television you may have seen a commercial for them and not even know it! For example – the popular arthritis or Crohn’s medications Enbrel and Humira are biologics.

Biologics are medications that are typically expensive and usually obtained from a specialty pharmacy. Biologics are generally not used as first line treatment but instead considered by your doctor after other less expensive treatment options have been tried and failed.

Now that you have an idea of what a biologic is, understanding what a biosimilar is should be relatively easy.

This analogy may help: Brand is to generic as biologic is to biosimilar . . . sort of.

Without getting too technical, biosimilars are basically the generic product of a biologic. However, because these medications are made out of living cells they will be slightly different.

What might you find a biologic or biosimilar made for?

Here are some examples of conditions or disease states that biologics or biosimilars may be made to treat:

What are some examples of biologics that are currently available?

Would there be an advantage to using a biosimilar compared to a biologic?

One advantage would be cost. Biosimilars could present a huge cost savings for patients and insurance companies once they are approved.

Does the FDA have an approval process in place for biosimilars?

Yes. The FDA has created a process for biosimilar approval that can be found here, and starting in summer 2014, several pharmaceutical companies have filed applications for approval of their exclusive biosimilar products. Some of these biosimilars may be available as soon as 2015.

Want more information?

The FDA answers some frequently asked questions regarding biologics here.

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