Oriama Ruth, Mudida Robert, Burger-Helmchen Thierry
In: Rezaei, N. (eds) Transdisciplinarity. Integrated Science, vol 5. Springer.
Année de publication : 2022

Biosimilar development is one of the extraordinary changes sweeping through the pharmaceutical industry, providing an opportunity for incremental innovation in the health bioeconomy domain. The dawn of the New Biology, global knowledge diffusion that inspires reverse innovation, and an increased political commitment to the real subsumption of nature through the bioeconomy characterize biosimilar development. These advancements come in the backdrop of high health-care costs and an ambition to achieve universal health care for all. This chapter argues that considerations of the multi-level perspective are necessary for a health bioeconomy transformation. Emerging borderless themes for biosimilar development include transdisciplinarity, harmonization, value chain diversifications, intellectual property, and knowledge diffusion. We describe the landscape of biosimilar development across different economic regions and present case examples of health research development and the place of incremental innovations. We elaborate on how regulation and public innovation policies become part of a multi-level governance system, especially in coordinated market economies. Presented themes for multi-level systems and transitions towards a health bioeconomy through biosimilar development involve different pathways leading to transformation, de-alignment, realignment, technological substitution, or reconfiguration. Dynamic interactions between the landscape, regime, and niche level ecosystems alongside the varieties of innovation contribute to this transformation. Finally, we recognize the role of regulatory harmonization in health preparedness and universal coverage. Biosimilars development has emerged as a strategic niche for unlocking the biophysical characteristics of nature. Learnings from complex multi-level systems can allow firms, governments, and individuals to invest in the biosimilar value chain innovatively.