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The implementation of the bioequivalence certification policy in Chile: an analysis of market authorization data

Kaplan, Warren A; Cárdenas, Jorge; Mansilla, Cristián; Tobar, Tatiana; Wirtz, Veronika J.

PLoS One; 14 (5), 2019

Affordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is e...

Access to Essential Medicines and Health Technologies, Generic Drug Policy, Drugs, Generic/supply & distribution, Therapeutic Equivalency, Drug Industry/organization & administration, Products Registration Certificate, Chile

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Evaluation of the effects of a generic substitution policy implemented in Chile

Chile implemented a generic substitution policy in 2014 to improve access to medicines. This study aims to measure if the generic substitution policy had an effect on the sales volume and prices of referent and the branded generic products with demonstrated bioequivalence (BEQ) in the private pharmaceuti...