Biosimilars 101

Have you heard people talk about biosimilar medicines and wondered what they are? Read on to learn more.

What is it?
As the name indicates, biosimilar drugs have similarities to biological medications. Products of living cells like animal cells and bacteria, biosimilars, are heavily regulated and meet rigorous regulatory standards before being approved for treatment. They shouldn’t be confused with generic drugs, which contain chemically synthesized molecules and are identical to their reference product.

What are the advantages?
Biosimilars are less costly to make than their reference biologic drug and require less research and development while ensuring identical treatment efficacy. Working the same way as their reference drug, they can often be switched and provide results without a clinically meaningful difference.

Do you have a question about your prescription drugs? Trust only your doctor and pharmacist to give you the best advice.

FDA and biosimilars
The U.S. Food and Drug Administration’s definition states that a biosimilar is “highly similar to” and “has no meaningful difference from” its reference drug. For a biosimilar to be interchangeable, it must meet additional requirements established by the Biologics Price Competition and Innovation Act.