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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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