Biosimilars are highly similar to the reference product notwithstanding minor differences in clinically inactive components. There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. Advances in current state-of-the art analytical methods enhance the likelihood that a product will be highly similar to another product by better targeting the original product’s physicochemical and functional properties.
Biosimilars – IP Strategy and Commercialization Aspects by Harshada Wadkar
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