巴西仿制药行业研究报告2010.pdfVIP

Estimations of generic drug entry in Brazil using count vs. ordered models Eduardo P.S. Fiuza Barbara Caballero IPEA IPEA September 24, 2009 Abstract Two major changes in Brazilian legislation during the 1990s reshaped the lo- cal pharmaceutical industry: the ratiÖcation of the TRIPs agreement including a provision for pipeline inventions in 1996, and a Generic Drug Act in 1999, which introduced bioequivalence tests and facilitated generic drugsí substitution for the pioneer drugs at dispensing. Price controls were gradually resumed in the turn of the century. Genuine generic drug entry may therefore be dated back to 2000, when the Örst applications were approved. The present article estimates entry of generic versions of o§-patent drugs into the various therapeutic classes using both count data and ordered multinomial models. Results point out that a simple Pois- son model Öts the data poorly, calling for further modelling of overdispersion or of excess zeros by applying Negative Binomial and zero-ináated count models. Or- dered models, however, seem to provide the best Öt of all. Most of the explaining variables utilized are signiÖcant, in particular lagged values of the revenues of the drug (proxy for potential market), number of own brands of the originatorís group, market concentration, and age of the pioneer drug. Av Pres. Antonio Carlos, 51 - 17o andar; Rio de Janeiro-RJ 20.020-010 - Brazil. E-mail (correspond- ing author): eduardo.Öuza AT .br. We thank Carla Marigo and Letici