Brazilian Regulation of Biosimilar Products: What Is Important to Know
This article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.
Ekaterina Myshenko - STOCK.ADOBE.COM
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.
Click here for a PDF of this article.Click here for Table IV and Appendices.Peer-Reviewed
Submitted: Feb. 3, 2022
Accepted: April 5, 2022
About the authors
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.
Article Details
BioPharm International
Vol. 35, No. 9
September 2022
Pages: 30–37
Citation
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) 30–37 (2022).
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
