FDA approved

 

What are biosimilars?

Biosimilars are highly similar versions of existing FDA-approved biologics, or reference products. Biosimilars undergo a rigorous evaluation to demonstrate that there are no clinically meaningful differences in structure, function, efficacy, and safety from their reference product.

Do biosimilars have the same side effects and safety profile as the originator product?

Biosimilars have no clinically meaningful differences from their reference products in terms of safety and effectiveness. Only minor differences in clinically inactive components are allowable in biosimilar products.

How long have biosimilars been prescribed?

Biosimilars have been available outside the United States (primarily in Europe, Canada, and Australia) since first being introduced in Europe in 2007.

The first biosimilar was approved in the United States in 2015, and, as of 2018, there are 10 available by prescription with at least 60 in development.

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