By N Griffith, A McBride, JG Stevenson, and L Green

Pharmacists will play a key role in evaluating biosimilars for formulary inclusion in the United States. As defi ned by US law, a biosimilar is a biologic that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and should not have clinically meaningful differences from its reference product in safety, purity, and potency.  This article reviews biosimilars and the current European Union and US regulatory pathways for biosimilars. A checklist is provided with considerations to ensure that US pharmacists thoroughly evaluate future biosimilars for formulary inclusion.

 

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