Recommendations on how to ensure the safety and effectiveness of biosimilars in Latin America: a point of view

Recommendations on how to ensure the safety and effectiveness of biosimilars in Latin America: a point of view Carlos Pineda 0 2 3 4 5 Carlo V. Caballero-Uribe 0 2 3 4 5 Marcia Gonclaves de Oliveira 0 2 3 4 5 Pedro Saul Lipszyc 0 2 3 4 5 Jose Julian Lopez 0 2 3 4 5 Marcelo Mario Mataos Moreira 0 2 3 4 5 Valderilio Feijo Azevedo 0 2 3 4 5 0 C. V. Caballero-Uribe Universidad del Norte , Barranquilla , Colombia 1 ) Research Direction, Instituto Nacional de Rehabilitacion , Mexico City , Mexico 2 V. F. Azevedo Federal University of Parana , Curitiba , Brazil 3 J. J. Lopez Centro de Informacion Medicamentos de la Universidad Nacional (CIMUN) , Bogota D.C. , Colombia 4 P. S. Lipszyc Department of Pharmacology, Medical School, University of Buenos Aires , Buenos Aires , Argentina 5 M. M. Mataos Moreira The use of biotechnology-derived medicines has significantly increased in recent decades. Although biosimilars undergo rigorous characterization as well as clinical studies to document their safety and effectiveness, they are highly complex molecules and small changes in the purification and production process of a biosimilar can have major implications in its safety and effectiveness profile. In Latin America, regulatory authorities have begun to establish welldescribed and standardized pathways that permit a biosimilar to gain commercial licensure. In order to be certain that a biosimilar reaches its potential in ordinary clinical use, an intensive post-licensing monitoring system must be established since it is the only means to ascertain the true similarity between the original biologic and its biosimilar. Pharmacovigilance allows national authorities to determine a drug's performance in the marketplace. An effective tracking and pharmacovigilance system for biological medicines has many steps and processes. To aid policy makers in Latin American in addressing the many issues surrounding the establishment of an effective pharmacovigilance system, the Americas Health Foundation convened a group of experts to discuss the topic and develop recommendations for implementation. The group discussed current challenges and gaps in pharmacovigilance in Latin America, paying close attention to the major issues associated with traceability and pharmacovigilance of biosimilars following their approval. The recommendations developed should enable countries to accurately document the safety and performance of a biosimilar as experienced by patients under real-life conditions and have a significant impact on the successful implementation of pharmacovigilance of biosimilars throughout the region. Biosimilars; Naming; Pharmacovigilance; Surveillance; Traceability - The use of biotechnology-derived medicines has increased dramatically in recent decades. As these products have come off patent protection, presumed biochemical and therapeutically equivalent products have been developed and have been termed biosimilars [1]. That is, a biosimilar is a biologic product that can be expected to produce the same therapeutic effect in any given patient had the original, or innovator, biologic medicine been given. Thus, biosimilars are considered to be similar in efficacy and safety to their reference products and as such are gaining widespread acceptance as suitably interchangeable medicines [2]. Although biosimilars undergo rigorous characterization as well as clinical studies to document their safety and effectiveness, the fact remains that they are highly complex biological molecules. Small changes in the production and purification process of a biological can have major implications in its safety and effectiveness profile [3]. Therefore, not only is thorough pre-clinical and clinical testing critical but demonstrating the true similarity of a biosimilar to its original product also requires careful documentation in post-marketing studies. The ability to trace and track a medicine introduced into the marketplace is essential. When given to large numbers of patients, it is not uncommon to document safety issues that were not seen in the controlled trials necessary for licensure. This is particularly important for biosimilars because of their multifaceted manufacturing processes and because, as stated above, it is not unreasonable to expect that there may be subtle differences in composition between a biosimilar and its reference product. Such differences may be revealed in an altered safety and effectiveness profile that is only detected when the medicine gains widespread use. In Latin America, regulatory authorities have begun to establish well-described and standardized pathways that allow a biosimilar to gain commercial licensure [1, 4]. In order to be certain that a biosimilar achieves its potential in ordinary clinical use, an intensive post-licensing monitoring system must be established since it is the sole means to ascertain the true similarity between the original biologic and its biosimilar. Unfortunately, few Latin American countries have such systems actively working to capture the relevant information. Pharmacovigilance (also known as surveillance) allows national authorities to determine a drugs performance in the m a r k e t p l a c e . T h e f i r s t c o m p o n e n t o f a n e ff e c t i v e pharmacovigilance system is the ability to track the medicine from manufacture to distribution to prescription. Then, there must be a system of pharmacovigilance that encourages and is able to document all adverse events that may be associated with the use of the medicine. Finally, the data derived from such reports must be carefully analyzed and reported to health professionals as well as to the manufacturer [57]. An effective tracking and pharmacovigilance system for biological medicines has many steps and processes. To aid policy makers in Latin American countries in addressing the major issues surrounding the establishment of an effective pharmacovigilance system, the Americas Health Foundation convened a group of experts to discuss the topic and develop recommendations for implementation. The group discussed the current challenges and gaps in pharmacovigilance in Latin America, paying close attention to the major issues associated with the traceability and pharmacovigilance of biosimilars following their approval. The recommendations presented below should enable countries to document accurately the safety and performance of a biosimilar as experienced by patients under real-life conditions. The name of the product is the foundation of product identification and is therefore absolutely essential for accurate record keeping and the subsequent attribution of adverse events. Currently, under the WHOs International Nonproprietary Name (INN) policy, the INN for a new biosimilar may be the same as that of the original biologic medicine. In such a case, if only the INN, without a distinguishable identifier, is used when prescribing a biologic medicine, an adverse event may be diff (...truncated)