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Accepted Paper:

What do ‘local’ biosimilars mean? Exploring Brazil’s international partnerships in biopharmaceutical production  
Nils Graber (University of Lausanne, Switzerland) Yves-Marie Rault-Chodankar (Paris 1 Panthéon-Sorbonne) Marilena Correa (State University of Rio de Janeiro)

Short abstract:

Brazil’s Partnership for Productive Development (PDP) policy has facilitated the local production of affordable generic drugs to meet national demands. This article explores the PDP’s role in transferring biosimilars revealing the intricate challenges in establishing local production in Brazil.

Long abstract:

The policies of Partnership for Productive Development (PDP) have permitted the rapid replication of antiretroviral drugs within both private and public Brazilian pharmaceutical laboratories, ensuring access within the national health system. This was achieved through ‘innovation through copy’ – i.e. reverse-engineering of original products, aimed at circumventing patents and enhancing production processes (Cassier and Correa 2003). However, the PDPs aimed at transferring the capacity for biosimilar production – copies of biopharmaceuticals derived from cell cultures – have failed to replicate the success of chemical generics. Only a few manufacturing capacities have been established, still reliant on importing key components. Additionally, there is a minimal price difference between the originator and the biosimilar. Our on-going fieldwork on the local production of biopharmaceuticals in Brazil sheds light on the challenges faced by the local industry in producing biosimilars and highlight how those differ from the generic sector. Specifically, we highlight the near absence of innovation-through-copy in biosimilar production. First, PDP policies governing biopharmaceuticals have led to a sluggish transfer process, including a mandated 10-years delay for foreign companies to transfer technology while building a monopoly on the Brazilian public market. Second, compliance with biosimilar regulations necessitates more stringent comparability studies compared to generics. Lastly, Brazilian public laboratories prioritize vaccine production, diverting attention from biosimilar development. Overall, we argue that biosimilars produced in Brazil rely on foreign key components, processes, and knowledge, prompting critical reflexion on the way a ‘copy’ is made and regulated in specific places (Greene 2014; Hayden 2007; Pollock 2019).

Traditional Open Panel P129
Transforming pharmaceutical innovation
  Session 2 Wednesday 17 July, 2024, -