Biosimilars/Biologic – A Biologic Drug Revolution

Biosimilars/Biologic medicines are large, complex molecules that are made in living cells grown in a laboratory. Biologic medicines are often 200 to 1,000 times the size of a small molecule or chemical drug such as aspirin. Due to both their large molecular size and fragile molecular structure, biologic medicines are almost always injected into the patient’s body.

It is approved based on demonstrating that it is highly similar to a FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

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