Abstract
Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.
Highlights
A generic drug is defined as a drug with the same active pharmaceutical ingredient (API), dosage form, safety, quality, and efficacy as the original proprietary drug, with which it can be interchangeable [1]
Between January 1, 2015, and December 31, 2015, 272 new, generics, and similar pharmaceutical drug products applications were published on Government Official Gazette
136 products were approved: 25 new drugs (10%), 99 generics (36%), and 12 similar drugs (4%). 136 generics and similar products had their registration refused by ANVISA
Summary
A generic drug is defined as a drug with the same active pharmaceutical ingredient (API), dosage form, safety, quality, and efficacy as the original proprietary drug, with which it can be interchangeable [1]. They were established in Brazil in 1999 to improve population access to low cost quality medicines. Similar drug products are present on Brazilian market for more years than generics They have the same API, dosage form, strength, indication, and posology of the original proprietary drug but are identified by a brand name [1]. Since 2014, all similar drugs have proved their therapeutic equivalence, so they can be interchangeable with reference drugs [5]
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