Abstract
ABSTRACTThe manufacturing process for biological products is complex, expensive and critical to the final product, with an impact on their efficacy and safety. They have been increasingly used to treat several diseases, and account for approximately 50% of the yearly budget for the Brazilian public health system. As the patents of biological products expire, several biosimilars are developed. However, there are concerns regarding their efficacy and safety; therefore, the regulatory agencies establish rules to approve and monitor these products. In Brazil, partnership programs between national government-owned companies and private technology holders have been implemented, aiming at knowledge sharing, capacity-building and technological transfer. Such partnerships locally promote manufacturing of these strategic drugs at reduced costs to the public health system. These agreements offer mutual advantages to both the government and patent holders: for the former, a biotechnological development flow is established and enables potential cost reduction and self-sufficient production; whereas for the latter, exclusive sales of the product are ensured during technological transfer, for a fixed period.
Highlights
The advent of biopharmaceuticals has completely transformed the treatment of different conditions. Their manufacturing process is complex and costly, requiring living organisms that produce large and complex molecular structures, and small changes in the conception and execution of this process may directly affect their efficacy and safety.[1]. The process is so critical to the final product that most manufacturers file for patents related to the manufacturing process and not necessarily the biologic agent per se
Since biologics use up a considerable portion of the national health care budgets, there is high financial pressure for the adoption of very similar copies, known as biosimilars.[3]. Considering these facts, the regulatory bodies and medical associations worldwide are challenged with establishing rules to determine the similarity degree of a biosimilar with its reference product, to ensure they have the same quality, efficacy and safety profile, which would allow for their approval and marketing
To discuss the most relevant topics related with the particularities of introducing biosimilars in the Brazilian market, we conducted a qualitative search of major health search databases (PubMed and LILACS), as well as databases of national and international health authorities and organizations (Brazilian National Health Surveillance Agency − ANVISA, Brazilian Ministry of Health, World Health Organization – WHO, Food and Drug Administration – FDA, and European Medicines Agency − EMA)
Summary
The advent of biopharmaceuticals has completely transformed the treatment of different conditions. Due to particularities in the production process, which is not publicly shared and disclosed by the originator company, the creation of an identical copy is virtually impossible, and this prevents the experience with generics (obtained by chemical synthesis) to be applicable to biologics. This gives rise to relevant questions and concerns related with efficacy, safety and immunogenicity of these products.[1,2,3]. The methods used to determine the comparability between biosimilars and their reference product must be sufficiently selective and specific to detect any differences between both The relevance of these differences can only be verified in pre-clinical and clinical trials. After the biosimilarity has been verified, there are still some controversial issues, such as the extrapolation of indications, the nomenclature of the new drug, and interchangeability, all based on the fact that the products are not identical molecules
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