ANVISA's role in biosimilar medicine regulation and innovation promotion

Biosimilars/Research | Posted 22/03/2024 post-comment0 Post your comment

The focus of the study by Vilha et al. [1] was to comprehend the role of the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (ANVISA), not only as a regulatory authority but also as a catalyst for technological development and innovation. ANVISA has implemented a significant change in the way health regulations are handled in Brazil.

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The pharmaceutical market holds outstanding relevance in economies due to its robustness and importance in societies. Economic development is intricately linked to social development, and within this production chain, the pharmaceutical industry stands out for its advanced developed and structured, particularly in R & D and innovation in some countries.

In Brazil, the strategic and economic importance of the pharmaceutical industry is underscored by the challenges and complexities of healthcare system in the country. The cut for biosimilar drugs was chosen based on their technological characteristics, as well as economic and social interest.

Recent studies on the national pharmaceutical industry, focusing on its innovative capabilities, indicate that the industry has not yet fully embraced the true essence of innovation, particularly radical innovation, despite the recognition of improved results demonstrated in recent decades, especially in incremental innovation [2-4].

Understanding the role of regulatory authority, the economic context, and how R & D and innovation efforts are organized in companies requires an interdisciplinary approach. This debate begins with the establishment of an interpretative foundation by economist John Keynes, demonstrating that capitalism lacks sufficient internal forces to generate stability in market performance [5]. Mazzucato highlights the importance of the State's leading role as an agent whose function must go far beyond minimizing market failures. It should be a State that is ‘directed, proactive, entrepreneurial, capable of assuming risks, and capable of creating a highly articulated system that takes advantage of the best of the private sector for the national good’ [6].

As a source of secondary data, Vilha et al. relied the management data published by ANVISA itself, as well as articles on biosimilars, and the regulatory pathways used in other countries. Finally, primary data were collected through interviews with former ANVISA employees.

The results demonstrate that ANVISA indirectly plays a role in promoting technological development and innovation, which can be understood as a stimulus to R & D. From the perspective of biosimilars, Vilha et al. emphasized that this is an even more crucial aspect due to the characteristics of this class of medicines. The authors noted that, in addition to aligning with international regulatory agencies, ANVISA has employed regulatory instruments that provide agility in decision-making.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Abstracted by Cátia Favale, Coordinator of the FAPESP PIPE Entrepreneur Programme and Project Manager consultancy, São Paulo, Brazil.

Editor’s comment
Readers interested to learn more about biosimilars in Brazil are invited to visit to view the following manuscript published in GaBI Journal:

Follow-on biologicals/biosimilars approved in Brazil: May 2023 update

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1. Vilha A, Favale C, Nachiluk K, et al. Medicamentos biossimilares: da regulação à promoção do desenvolvimento tecnológico e inovativo pela ANVISA. Revista de Gestão e Secretariado (Management and Administrative Professional Review). 2023;14(7):12320-38. 
2. Centro De Gestão E Estudos Estratégicos – CGEE. Competências para inovar na indústria farmacêutica brasileira. Brasília; DF. 2017. p. 126.
3. Reis C, le Lemos Capanema LX, Pieroni PL, et al. Biotecnologia para saúde humana: tecnologias, aplicações e inserção na indústria farmacêutica. BNDES Setorial. 2009;29:359-92.
4. De Negri, F.  Novos caminhos para a inovação no Brasil. Washington, DC; Wilson Center. 2018. p. 159.
5. Donário AA, Borges dos Santos R. Centro de Análise Econômica de Regulação Social CARS. Janeiro. Universidade Autônoma de Lisboa: Portugal. 2016.
6. Mazzucato M.  O estado empreendedor: desmascarando o mito do setor público vs setor privado. São Paulo; Portfolio-Penguin. 2014. p. 58-108.

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