Bio-avilability and Bio-equivalence

Bio availability is the rate and extent of active drug absorbed and available for action. Assessment of “interchangeability” between the generic and the innovator product is carried out by a study of bioequivalence (BE). During formulation of new entities bio availability and bio equivalents are also prime parameters. Through the conduct of bioavailability and bioequivalence studies, Generic drug products results on average bioequivalence in drug absorption. The top 15 biopharmaceutical products each profits annual revenue of more than $2 billion, with some drugs generating sales of more than $10 billion a year. In 2015 the top NMEs include Pfizer’s Ibrance, J&J’s Darzalex and Gilead’s Genvoya with a cumulative value of $32bn of sales expected in 2020.

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