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The process is the product axiom means biosimilarity is achievable but identity is not, which is why the BPCIA operates on a highly similar standard rather than a bioequivalence standard

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65 years), baseline eGFR ( 40%), treatment with 10 mg empagliflozin for a median time of 26.2 months reduced the risk of a composite of CV death or hospitalization for HF by 21%, and effect which was mainly related to a 29% lower risk of hospitalization for HF

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