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Biosimilars are a type of biological product that is highly similar to an already approved biological product (e.g., the biological reference product). These products have been tested to demonstrate no clinically meaningful differences from the reference product. Biosimilars are not generic copies (i.e., a bioequivalent) of the biological reference product. Although similar to the relevant reference product, they have ‘allowable differences’ given they’re made from living organisms. In terms of safety, purity and potency, an approved biosimilar has no clinically meaningful differences from the reference product.
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