Latin America's biosimilars market: regulatory, institutional, and technological aspects

According to a study led by Bas (2023), the Latin American (LA) biosimilars market is positioned for substantial growth over the next decades as a cost-effective alternative to expensive patented biomolecules [1].

This expansion is propelled by the imperative of accessible health care, rising chronic diseases, imminent biological patent expirations, and the integration of artificial intelligence (AI) technologies.

Notably, Argentina, Brazil, and Mexico have taken significant strides by establishing regulatory frameworks governing biosimilar endorsement and investing in local manufacturing, sales, and distribution. However, amidst this promising landscape, LA confronts challenges rooted in inadequate institutional frameworks and insufficient public policies, hindering the harmonization of biosimilar regulations. A critical facet to consider is the escalating cost associated with the R & D of novel biomolecules, which has kindled a preference for biosimilars. The expiration of patents presents a crucial opportunity for biosimilars to enter the market of cost-effective alternatives. The effectiveness of this hinges upon robust regulations and the institutional frameworks charged with enforcing them across LA. However, variations among LA nations underscore the challenge of harmonization, necessitating concerted efforts to improve both regulatory and institutional quality.

AI's transformative potential is paramount, poised to expedite processes and enhance efficacy across biosimilar R & D phases. However, achieving this requires the adaptation of existing regulations to standardize AI-integrated processes regionally, transcending isolated initiatives in countries like Argentina, Brazil, and Mexico. As these nations exhibit varying capabilities, the alignment of public policies governing biosimilar regulations becomes imperative. The inconsistent institutional quality across these countries poses a significant obstacle to regulatory uniformity. Addressing this shortfall is pivotal in fostering a thriving biosimilar industry that caters to all segments of society.

Furthermore, enhancing the competencies of healthcare professionals in biomolecules development, in the use of AI and ensuring the corresponding infrastructure are essential for realizing the potential of biosimilars. This requires substantial investments from the public and private sectors, as well as consistent governmental policies. AI also plays a crucial role in maintaining quality standards throughout the biosimilar development process.

With population growth and longer lifespans leading to an increase in diseases, the costs associated with biomolecule development are expected to rise. It is imperative to establish consensus on criteria to promote wider biosimilar adoption across LA, thereby mitigating the risk of a substantial portion of the population being denied of quality treatments due to financial constraints.

Although the expiration of numerous patents presents complexities, it holds significant benefits for the biosimilar industry, governments and patients alike. This transition fosters stability in treating complex illnesses like oncological conditions. To harness this potential, conducting a thorough assessment of expiring ‘blockbuster’ patents and their potential as impactful biosimilars is essential. Contrary to stifling innovation, biosimilars play a pivotal role in rendering quality medicines accessible to socioeconomically disadvantaged individuals. Coexisting alongside innovative drugs, they cater to distinct markets and purposes, contributing to the dynamism of the pharmaceutical landscape.

The author concluded that the LA biosimilars market demands the convergence of several factors: the interplay of regulations, institutional quality, affordability, competent human capital, and the strategic integration of AI. Harmonizing regulations across LA to align with international standards holds the potential to expedite approvals and enhance efficacy. The biosimilars landscape offers substantial opportunities for LA, anchored in comprehensive regulatory frameworks, robust institutions, and dynamic technological integration.

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

Abstracted by Associate Professor Tomas Gabriel Bas, PhD, Universidad Católica de Norte, ECIEM, Coquimbo, Chile.

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Current trends for biosimilars in the Latin American market

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Reference
1. Bas, TG. Biosimilars for the next decade in Latin America: a window of opportunity. Expert Opinion on Biological Therapy, 2023.
https://www.tandfonline.com/doi/full/10.1080/14712598.2023.2245780?needAccess=true

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