Partnership for productive development of biosimilar products: perspectives of access to biological products in the Brazilian market

Abstract

The 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.

Relationship between innovative and biosimilar trastuzumab used in the treatment of breast cancer: cross-sectional study of financial impact

“…According to Scheinberg et al, 18 the development process of biological medicines is costly and complex, as it is based on the production of large and complex molecules by living organisms, whose small changes in the generation and execution of the process can directly affect the efficacy and safety. Grabowski et al, 19 estimate that the costs involved with research and development of biosimilars vary between 10 and 40 million dollars, and the investments for their production vary between 250 and 450 million dollars.…”

Marcos regulatórios das políticas de fomento de medicamentos biológicos na América Latina: o que há de novo? / Regulatory frameworks for policies to promote biological medicines in Latin America: what is new?

“…O anticorpo monoclonal Remsima® (infliximabe) foi o primeiro medicamento biossimilar comercializado no Brasil. Seu processo de produção ocorreu por meio de uma PDP, empregando-se transferência de tecnologia (SCHEINBERG et al, 2018). Tratou-se de uma pareceria entre laboratórios privados e o laboratório público oficial Bio-Manguinhos (BIO-MANGUINHOS, 2015;SCHEINBERG et al, 2018).…”

“…Seu processo de produção ocorreu por meio de uma PDP, empregando-se transferência de tecnologia (SCHEINBERG et al, 2018). Tratou-se de uma pareceria entre laboratórios privados e o laboratório público oficial Bio-Manguinhos (BIO-MANGUINHOS, 2015;SCHEINBERG et al, 2018). O medicamento está disponível no mercado desde 2016 (ANVISA, 2015;SCHEINBERG et al, 2018).…”

“…Tratou-se de uma pareceria entre laboratórios privados e o laboratório público oficial Bio-Manguinhos (BIO-MANGUINHOS, 2015;SCHEINBERG et al, 2018). O medicamento está disponível no mercado desde 2016 (ANVISA, 2015;SCHEINBERG et al, 2018). Segundo a Bio-Manguinhos, mais de 80% dos frascos de infliximabe adquiridos pelo MS em 2015 provinham desta parceria, o que se reflete em um total aproximado de 180 mil frascos, a um custo de R$175 milhões (BIO-MANGUINHOS, 2015).…”

Why are biosimilars much more complex than generics?

“…Almost all tests demanded for an innovative biologic drug shall be made in comparison to the reference drug for a biosimilar. ( 7 , 8 ) This is called comparability exercise, and includes physical-chemical assessments, functional assays, animal tests, and clinical trials.…”