The challenges of developing and commercializing biosimilars in Latin America

摘要

Noninnovator biopharmaceutic products have been coined biosimilars, as they differ from generics, according to the WHO [1]. At present, the biosimilar market is highly dynamic worldwide, Latin America being no exception. The Latin American pharmaceutical market represents approximately 25% of global sales [2]. Latin America possesses an emerging market of high complexity because, notwithstanding cultural and linguistic similarities, there is a vast diversity in terms of drug regulation and political regimes [3,4]. In recent years, however, there have been significant advances in biosimilar regulation pathways among all Latin American countries, despite quite different pharmaceutical environments [3]. The three major players in this region are Mexico, Brazil and Argentina, not only due to their market size, but also for having national industries capable of developing biopharmaceutics. These three countries, however, have undertaken diverse strategies for development, regulation and commercialization of biosimilars [3,4]. Brazil is the biggest and most attractive pharmaceutical market in Latin America. For drug products, and particularly for biosimilars, the Brazilian government has implemented the Productive Development Partnership program. According to this program, local laboratories, government and foreign biosimilar developers should work together in order to facilitate technology transfer to allow biosimilar manufacture by the national industry. In return, the government has established the compromise to grant purchase preferences by the Brazilian public health system to biosimilars manufactured under this program. Important cost reductions and increases in access are expected from local manufacture, while the participating foreign companies can expect significant profits due to the size of the Brazilian market [5]. In Argentina, although there is no explicit partnership program as in Brazil, the government has clearly shown a preference toward locally developed biosimilars [3]. In contrast, in Mexico, the second largest drug market in Latin America, the government has not yet implemented any program to support biosimilar production by local industries. Moreover, intended copies, not true biosimilars, have been developed, commercialized and later withdrawn in Mexico [3,4]. Intended copies are noninnovator products that do not comply with all the requirements established by WHO guidelines [6]. This has led to a lack of trust on locally developed products. As a consequence, the role of the Mexican industry at present is being reduced to the commercialization of foreign biosimilars. The cases of locally manufactured rituximab biosimilars are useful to illustrate the differences in the biosimilar market among the three larger Latin American countries.