What is the difference between biosimilars and generics

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Was the information on this page useful to you? Did you encounter any problems while navigating? Please do not enter any personal information in this field. Note that you will not receive a reply. For a biosimilar drug to receive FDA approval, it must be highly similar to the original biological drug and contain no clinically meaningful differences, although there may be minor differences in clinically inactive ingredients. So, they cost more than generics, but less than the branded biologic.

In general, generic drugs cost 40 percent to 50 percent less than the brand product, Joy says. Biosimilars, in contrast, are closer to 15 percent to 20 percent cheaper because of the amount the drug manufacturer has to spend on testing.

So far, the FDA has approved 12 biosimilars. Like trastuzumab, the biosimilar will treat certain people with breast or metastatic stomach cancers that contain an excess amount of the HER2 protein.

Make a difference in the fight against cancer by donating to cancer research. Call us anytime. However, just like many biological molecules, biosimilars are very sensitive to storage and handling conditions, so they need to be stored under adequate conditions starting from when they are developed. Another difference between the two products is that generic drugs have virtually no immunogenic potential, which means they cannot generate an immune response, while biosimilars, just like biological reference drugs, could be immunogenic.

Given the simplicity of generic drugs and no need for other complex modifications, it is easy to produce exact copies of them, which makes the manufacturing process easy and predictable.

On the other hand, both biosimilars and their reference drugs are not synthesised through a simple chemical reaction like generic drugs. They require a complex biotechnological process in a cellular environment like any protein from the body.