What are Biosimilars?

Many of you have seen in the news recently about "new biosimilars" that are coming out, but what exactly is a biosimilar? Will it affect your treatment? Does it have the same side effects? Are they the same as generic drugs? Here is the answers to all your questions.

A Biosimilar is a biological product that is highly similar to a reference product, no clinical meaningful difference from the reference product in safety, purity, or potency, and is approved by the FDA after rigorous evaluation and testing. Prescribers and patients should have no concerns about using these medications instead of reference products. All biosimilars meet FDA's rigorous standards, they are all manufactured at FDA-Licensed facilities, and are tracked as a part of post-market surveillance to ensure continued safety.

Biosimilar drugs are often confused with generic drugs. Both are marketed as cheaper versions of costly name-brand drugs. Both are available when drug companies’ exclusive patents on expensive new drugs expire. And both are designed to have the same clinical effect as their pricier counterparts. But biosimilar drugs and generic drugs are very different, mainly because while generic drugs are identical to the original in chemical composition, biosimilar drugs are "highly similar" but close enough in duplication to accomplish the same therapeutic and clinical result. Another key difference is that generics are copies of synthetic drugs, while biosimilars are modeled after drugs that use living organisms as important ingredients.

All in all, biosimilars must be highly similar to the original biological drug and contain no clinically meaningful difference, therefore not affecting your treatment.

Be on the lookout for new biosimilars for several chemotherapys on the market in the near future and ask your doctor here at Charleston Oncology if you are concerned about anything related to your treatment.

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