@article{ARAUJO_MOSEGUI_VIANNA_VILLAR_CATAO_2020, title={REFLECTIONS AND PERSPECTIVES ON BIOSIMILARS IN BRAZIL}, volume={12}, url={https://journals.innovareacademics.in/index.php/ijpps/article/view/37903}, DOI={10.22159/ijpps.2020v12i7.37903}, abstractNote={<p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: ’Cambria’,’serif’;">Objective: </span></strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: ’Cambria’,’serif’;">Biological agents are among the medicines with the highest revenue in the world market. Biosimilars are copies of biological products introduced into the market to offer clinical efficacy like the originator or reference product at lower prices. This study aimed to verify the characteristics and price differences between biological medicines registered and marketed in Brazil until the end of 2019.</span></p> <p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: ’Cambria’,’serif’;">Methods: </span></strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: ’Cambria’,’serif’;">All records were collected by November 2019 on the website of the National Health Surveillance Agency (Anvisa). The list of the Chamber of Regulation of the Medicines Market (CMED) consulted for the price analysis, has an economic classificatory criterion with eight ranges. Categorization, according to the date/period of authorization for marketing, was also made.</span></p> <p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: ’Cambria’,’serif’;">Results: </span></strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: ’Cambria’,’serif’;">At Anvisa site, there are 144 drugs present in 277 products distributed in three regulatory categories: new, biological, and similar. Approximately 73% of drugs have been approved in the past five years. Three classes represent 77.9% of all drugs-antineoplastics and immunomodulatory agents (38.6%), blood and blood organ forming (20.7%), and alimentary tract and metabolism (18.6%). Of the 178 products listed in the CMED, 26 (14.6%) have prices above 10,000 reais.</span></p> <p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: ’Cambria’,’serif’;">Conclusion: </span></strong><span lang="EN-IN" style="font-size: 8.0pt; font-family: ’Cambria’,’serif’;">The prices of original products, for most of the inputs, are lower than those of biosimilars, reversing the international logic.</span></p>}, number={7}, journal={International Journal of Pharmacy and Pharmaceutical Sciences}, author={ARAUJO, RENATA LUZES and MOSEGUI, GABRIELA BITTENCOURT GONZALEZ and VIANNA, CID MANSO D. E. MELLO and VILLAR, FERNANDO ANTONANZAS and CATAO, THAIS PEREIRA}, year={2020}, month={Jul.}, pages={26–31} }