Pharmaceutical equivalence of oncology products marketed in Brazil

Marcus Augusto Lyrio Traple; Rosa  Noriko Yamamoto; Daniela Dal Molin Ghisleni; Rogério Takao Okamoto; Elisabete Almeida Barbosa; Terezinha de Jesus  Andreoli Pinto; Felipe Rebello Lourenço

Marcus Augusto Lyrio Traple
Rosa Noriko Yamamoto
Daniela Dal Molin Ghisleni
Rogério Takao Okamoto
Elisabete Almeida Barbosa
Terezinha de Jesus Andreoli Pinto
Felipe Rebello Lourenço

Keywords: Therapeutic Equivalence. Medical oncology. Cisplatin. Doxorubicin. Paclitaxel

Abstract

The aim of this work was to assess pharmaceutical equivalence among medicinal products containing cisplatin, doxorubicin hydrochloride and paclitaxel that are marketed in Brazil by various manufacturers. We analyzed 14 lots of cisplatin injectable solution from 4 manufacturers (Labs B, C, H and I), 15 lots of doxorubicin hydrochloride injectable lyophilized powder from 5 manufacturers (Labs C, F, G, H and J) and 38 lots of paclitaxel injectable solution from 8 manufacturers (Labs A, B, C, D, E, F, G and H). All products complied with the criteria established in the Brazilian and American pharmacopoeias. The assay results for contents of cisplatin, doxorubicin hydrochloride and paclitaxel were 94.3-105.9%, 97.1- 106.6% and 90.2-109.4%, respectively. Statistical analysis showed that the same products from the various manufacturers were equivalent.