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Biosimilars and Heterogeneous Technological Trajectories in the Argentine Biopharmaceutical Industry

Published online by Cambridge University Press:  29 December 2023

Pablo José Lavarello
Affiliation:
CENTRO DE ESTUDIOS URBANOS Y REGIONALES (CEUR), CONSEJO NACIONAL DE INVESTIGACIONES CIENTÍFICAS Y TECNOLÓGICAS (CONICET), BUENOS AIRES, ARGENTINA
Graciela Gutman
Affiliation:
CENTRO DE ESTUDIOS URBANOS Y REGIONALES (CEUR), CONSEJO NACIONAL DE INVESTIGACIONES CIENTÍFICAS Y TECNOLÓGICAS (CONICET), BUENOS AIRES, ARGENTINA
Juan José Pita
Affiliation:
CENTRO DE ESTUDIOS URBANOS Y REGIONALES (CEUR), CONSEJO NACIONAL DE INVESTIGACIONES CIENTÍFICAS Y TECNOLÓGICAS (CONICET), BUENOS AIRES, ARGENTINA

Abstract

This paper will review the strategies and learning trajectories followed to tap the opportunities opened by the successive waves of biotechnologies: early imitators followed by late imitators in the first generation of biosimilars (erythropoietin, insulins, interferons), and then sequential entry and skipping stages during the second generation (monoclonal antibodies).

Type
Symposium Articles
Copyright
© 2023 The Author(s)

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References

Bianchi, C., “A Indústria Brasileira de Biotecnologia: montando o quebra-cabeça,” Revista Economia & Tecnologia 9, no. 2 (2013): 99116; C. Bianchi, “Brazilian Health Biotechnology Innovation System: An Essay about the Public Policy Rationale,” Fronteiras: Journal of Social, Technological and Environmental Science 5, no. 1 (2016); J. Dirk, Reconfiguration of a Latecomer Innovation System: Governing Pharmaceutical Biotechnology Innovation in South Korea (Frankfurt; Peter Lang Pub., 2013); V. Vargas, M. Rama, and R. Singh, Pharmaceuticals in Latin America and the Caribbean: Players, Access, and Innovation across Diverse Models (Washington, D.C.: The World Bank, 2022); S. Guennif and S. Ramani, “Explaining Divergence in Catching-Up in Pharma between India and Brazil Using the NSI Framework,” Research Policy 41, no. 2 (2012): 430-441; J. Niosi, T. Bas, and J. Flores, “Biopharmaceuticals in Latin America: Challenges and Opportunities,” Innovation and Development 3, no. 1 (2013): 19-36.Google Scholar
Gutman, G. and Lavarello, P., Biosimilar Corporate Strategies in Argentina during the 2000s: Technological and Organizational Learning for Internationalization (2017), CEUR-CONICET, Mimeo.Google Scholar
Lavarello, P., Gutman, G., and Sztulwark, S., “Crisis y recomposición de la industria biofarmacéutica mundial: ¿existen espacios estructurales para los países en desarrollo?” in Explorando el camino de la imitación creativa: La industria biofarmacéutica argentina en los 2000, 1ra ed. (Libro Punto, 2018); P. Lavarello, G. Gutman, and S. Sztulwark, Explorando el camino de la imitación creativa: La industria biofarmacéutica argentina en los 2000 (Buenos Aires: CEUR-Editorial Libro Punto, 2018); CEPAL, “La salud como desafío productivo y tecnológico: capacidades locales y autonomía sanitaria en la Argentina pospandemia”, Documentos de Proyectos (LC/TS.2020/172 LC/BUE/TS.2020/2), Santiago, 2020.Google Scholar
This paper presents a comprehensive overview and analysis of the findings from the CEUR PICT 2034 Project titled “Business Strategies in the Face of the Biotechnological Revolution: The Case of the Biopharmaceutical Industry in Argentina.” The general outcomes of this project have been published in Lavarello, Gutman, and Sztulwark’s work, supra note 2, CEUR CONICET, as well as in Gutman and Lavarello’s publication titled “Biotecnología industrial en Argentina. Estrategias empresariales frente al nuevo paradigma” (2014), published by Letra Prima, CEUR-CONICET. We are especially grateful to Ken Shadlen, Veronica Vargas, and Martin Rama for their comments on the preliminary version of this article. The conclusions of the article are the sole responsibility of the authors.Google Scholar
A. Gerschenkron, “El atraso económico en perspectivahistórica,” Investigación Económica 28, núm. 111/112 (Junio-diciembre, 1968), UNAM, México.Google Scholar
Bell, M. and Pavitt, K., “The Development of Technological Capabilities,” in ul Haque, I., ed., Trade and International Competitiveness, Economic Development Institute (Washington, D.C.: The World Bank, 1995).Google Scholar
Pérez, C. and Soete, L., “Catching Up in Technology: Entry Barriers and Windows of Opportunity,” in Dosi, G., Freeman, C., Nelson, R., and Silverberg, G., (1988). Technical Change and Economic Theory (Pinter Publishers, 1988); C. Pérez, “Cambio tecnológico y oportunidades de desarrollo como blanco móvil,” Revista de la CEPAL 75 (2001): 115-136.Google Scholar
See Lavarello, et al, supra note 2; Kim, L., Imitation to Innovation: The Dynamics of Korea’s Technological Learning (Cambridge: Harvard Business School Press, 1997), available at <https://books.google.com.ar/books?id=ey2ZoWyc2jQC> (last visited July 11, 2023); P. Lavarello, S. Sztulwark, M. Mancini, and S. Juncal, “Creative Imitation in Late Industrializing Countries: The Case of Biopharmaceutics in South Korea and India,” Innovation and Development (2021): 1-20.Google Scholar
Gutman, G. and Lavarello, P., “Biopharmaceuticals and Firm Organization in Argentina. Opportunities and Challenges,” International Journal Technology and Globalization 7 (2014): 159159.CrossRefGoogle Scholar
Pisano, G., Science Business: The Promise, the Reality and the Future of Biotech (Harvard Business School Press, 2006); G. Pisano, “Profiting from Innovation and the Intellectual Property Revolution,” Research Policy 35, no. 8 (2006): 1122–1130; B. Coriat, F. Orsi, and O. Weinstein, “Does Biotech Reflect a New Science-Based Innovation Regime?” Industry & Innovation 10, no. 3 (2003): 231-253; M. Hopkins, P. Nightingale, A. Kraft, and S. Mahdi, “The Myth of the Biotech Revolution: An Assessment of Technological, Clinical and Organisational Change,” Research Policy 36 (2007): 566-589; I. Cockburn and S. Stern, “Finding the Endless Frontier: Lessons from the Life Science Innovation System for Technology Policy,” Capitalism and Society 5, no. 1 (2010); Gutman and Lavarello, supra note 8.Google Scholar
Lavarello, P., “Corporate Knowledge Diversification in the Face of Technological Complexity: The Case of Industrial Biotech,” Structural Change and Economic Dynamics 38 (2016): 95105.CrossRefGoogle Scholar
Lavarello, P., Goldstein, E., and Pita, J., “Sustitución de Importaciones en la Industria Biofarmacéutica Argentina: Una Estrategia con Blanco Móvil,” Journal of Technology Management & Innovation 12, no. 1 (2017): 8492; Lavarello, et al., supra note 3.Google Scholar
Abernathy, W. and Utterback, J., 1978. “Patterns of Industrial Innovation,” Technology Review, 40 (1978): 4047; W. Lazonick and Ö Tulum, “US Biopharmaceutical Finance and the Sustainability of the Biotech Business Model,” Research Policy, 40, no. 9 (2011): 1170–1187; M. Mazzucato and G. Dosi, eds., Introduction a Knowledge Accumulation and Industry Evolution: The Case of Pharma-Biotech (Cambridge: Cambridge University Press, 2006): 1-18; G. Dosi, “Technological Paradigms and Technological Trajectories: A Suggested Interpretation of the Determinants and Directions of Technical Change,” Science Policy Research 11 (1982): 147-162.Google Scholar
See Lavarello, et al., supra note 3.Google Scholar
Yin, R., Case Study Research: Design and Methods, 3rd ed. (Sage Publications, 2003).Google Scholar
K. Shadlen, Policy Space for Development in the WTO and Beyond: The Case of Intellectual Property Rights (No. 1434-2016-118855) (2015); Sampat, B.N. and Shadlen, K.C., “Secondary Pharmaceutical Patenting: A Global Perspective,” Research Policy 46, no. 3 (2017): 693707; K. Shadlen, Coalitions and Compliance: The Political Economy of Pharmaceutical Patents in Latin America (New York/Oxford: Oxford University Press, 2017).CrossRefGoogle Scholar
C.M. Correa, “Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing,” Research Paper, South Centre, 2011, at 41.Google Scholar
Argentina became a signatory of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) by enacting Law No. 24,481/1995 on Patents of Invention. In 2000, the National Institute of Industrial Property (INPI) was established.Google Scholar
The Joint Resolutions 118/2012, 546/2012, and 107/2012 were enacted.CrossRefGoogle Scholar
Berkowitz, S.., Engen, J., Mazzeo, J.., and Jones, G., “Analytical Tools for Characterizing Biopharmaceuticals and the Implications for Biosimilars,” Nature Reviews Drug Discovery 11, no. 7 (2013): 527–40.Google Scholar
P. Lavarello and M. Minervini, “El rol de la compra pública en la sustitución de importaciones de biológicos en Argentina,” Documento preparado para el Proyecto PICT 2034, Estrategias empresariales frente a la revolución biotecnológica: el caso de la industria biofarmacéutica en Argentina, Buenos Aires, inédito (2015); Lavarello, P., Minervivi, M., Robert, V., and Vázquez, D., “Las políticas orientadas por misiones: el debate en los países centrales y su aplicación en el contexto de países en desarrollo”, in Suarez, D., Erbes, A., and Barletta, F., eds., (Comp), Teoría de la innovación: evolución, tendencias y desafíos. Herramientas conceptuales para la enseñanza y el aprendizaje . UNGS-UCM, Buenos Aires, Madrid (2020).Google Scholar
Gutman and Lavarello, supra note 2; Lavarello, et al., supra note 3.Google Scholar
Lavarello, et al., supra note 3; Gutman and Lavarello, supra note 9.Google Scholar
Initially, the company operated as a specialized entity under the pharmaceutical group.Google Scholar
The National Institute of Industrial Technology (INTI) possesses a bioprocess plant where firms carry out product developments to facilitate technology transfer. In addition, activities such as production scaling and implementing quality systems in existing processes are conducted. The plant is designed to accommodate a wide range of microorganisms and processes for applications in producing raw materials for biopharmaceuticals, food additives, and other industrial processes.Google Scholar