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This article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.
Since the publication of the Resolution of the Collegiate Board of Directors (RDC) biosimilars regulations, RDC 55/2010, by Anvisa, 43 biosimilar products have been approved in Brazil as of Dec. 31, 2021. The European Medicines Agency, however, is the more advanced regulatory authority, having issued its Guideline on Similar Biological Medicinal Products in 2005 and having recommended the approval of 84 biosimilars as of the time of this paper’s writing. In comparison, in the United States, FDA gained the ability to approve biosimilars (including interchangeable biosimilars that are substitutable with their reference product) in 2010 under the Patient Protection and Affordable Care Act issued by the US government on March 23, 2010. Following this, the first biosimilar in the US was approved in 2015, and as of Dec. 31, 2021, 34 biosimilars had been approved by FDA, among them was an interchangeable biosimilar (Mylan’s insulin glargine, Semglee). Biosimilars are an alternative for reducing costs and enabling savings for healthcare systems, especially in countries where biological drugs are less affordable; however, biosimilars must still undergo strict regulatory scrutiny, including in countries outside the US and European Union. To that end, this article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.
Submitted: Feb. 3, 2022
Accepted: April 5, 2022
Sílvia Helena Cestari de Oliveira*, silvia.biotec@ cristalia.com.br, is researcher in the biotechnology division at Cristália Produtos Químicos Farmacêuticos, Itapira, Brazil; Marcos Castanheira Alegria is R&D director at Hypera Pharma; and Marco Antonio Stephano is professor at the University of Sao Paulo, Sao Paulo, Brazil.
*To whom all correspondence should be addressed.
Vol. 35, No. 9
When referring to this article, please cite it as S. Cestari de Oliveira, et al., “Brazilian Regulation of Biosimilar Products: What Is Important to Know,” BioPharm International 35 (9) 36–40 (2022).