Abstract
Objective: 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.
 Methods: 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.
 Results: 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.
 Conclusion: The prices of original products, for most of the inputs, are lower than those of biosimilars, reversing the international logic.
Highlights
Just over twenty years ago, biological or biopharmaceutical medicines revolutionized the treatment of numerous diseases, including severe chronic conditions, such as diabetes, autoimmune diseases, hematological diseases, and cancer [1, 2]
Surveillance Agency (Anvisa), defines drugs whose molecule with known biological activity is already registered in Brazil as non-new biological products and those not yet registered in Brazil as new biological products
Because biological products registered by this alternative are similar to biosimilars but do not have this denomination in the country, it is only possible to identify them by analyzing their dossier or, if they appear in the search on Anvisa's webpage, the name of the original medicines with which they are comparable
Summary
Just over twenty years ago, biological or biopharmaceutical medicines revolutionized the treatment of numerous diseases, including severe chronic conditions, such as diabetes, autoimmune diseases, hematological diseases, and cancer [1, 2] These agents have an intrinsic complexity that relates to differentiated research and development (R and D) and manufacturing processes that are difficult to execute, as they are dependent on living organisms [3]. They are associated with specific regulatory processes and extensive clinical applicability in the treatment of complex diseases [4,5,6] Effective, their high R and D and production costs limit their access and use, especially in emerging countries, where they can pose a threat to the sustainability of health systems [2, 7]. The international price reduction, which, on average, does not exceed 30% [11,12,13], can ease pressure on the health budget by facilitating patients' access to innovative treatments [2]
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