“Breakthrough” drugs and growth in expenditure on prescription drugs in Canada

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Abstract
Between 1990 and 2003, the board appraised 1147 newly patented drugs (identified by active ingredient(s), formulation, and strength), including derivatives of existing medicines, such as esomeprazole. Of these new drugs, 68 (5.9%) met the regulatory criterion of being a breakthrough drug (“the first drug to treat effectively a particular illness or which provides a substantial improvement over existing drug products”).2 These included, for example, filgrastim, donepezil hydrochloride, and infliximab. We expanded the criterion for being a breakthrough drug, however, to include all subsequent formulations and dosages of a classified breakthrough drug, as well as all competing drugs to enter the chemical subgroup3 established by a classified breakthrough drug. All variants on a breakthrough drug were therefore also classified as breakthroughs. This increased the number of breakthrough products in our study to 142.

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