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A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy

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Abstract

Background

Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments.

Objective

This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries.

Method

This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage.

Results

Brazil had the highest median price reduction (− 36.3%) in biosimilars price, followed by Italy (− 20.0%) and Argentina (− 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2).

Conclusion

The study revealed a marked dispersion in the price’s differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies.

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Data availability

Data will be made available on request.

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Funding

No funding was received to conduct this research.

Author information

Authors and Affiliations

  1. Instituto de Ciências Farmacêuticas, Universidade Federal Do Rio de Janeiro, Macaé, Rio de Janeiro, Brazil

    Fernanda Lacerda da Silva Machado

  2. Sorocaba University, Sorocaba, São Paulo, Brazil

    Fernanda Lacerda da Silva Machado & Luciane Cruz Lopes

  3. Universidad Nacional Arturo Jauretche-FEMEBA, La Plata, Argentina

    Martín Cañás & Martín A. Urtasun

  4. Universidad Nacional de La Plata-CONICET, La Plata, Argentina

    Gustavo H. Marín

  5. Brazilian Industry Association of Active Pharmaceutical Ingredient, São Paulo, Brazil

    Flavia Caixeta Albuquerque

  6. University of Technology Sydney, Sydney, Australia

    Lisa Pont

  7. Unit of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy

    Irma Convertino, Marco Bonaso & Marco Tuccori

  8. Department of Epidemiology, Lazio Regional Health Service, Rome, Italy

    Ursula Kirchmayer

Authors
  1. Fernanda Lacerda da Silva Machado
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  11. Luciane Cruz Lopes
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Contributions

The study was conceptualized and designed by FLSM and LCL. All authors participated in data collection and analysis for at least one country. Argentina: MC, MAU and GHM; Australia: LP; Brazil: FCA and FLSM; Italy: IC, MB, MT and UK. Data collected was further compiled by FLSM. The first draft of the manuscript was written by FLSM and revised by the other authors. All authors read and approved the final version of the manuscript.

Corresponding author

Correspondence to Luciane Cruz Lopes.

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da Silva Machado, F.L., Cañás, M., Urtasun, M.A. et al. A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy. Ther Innov Regul Sci 58, 549–556 (2024). https://doi.org/10.1007/s43441-024-00623-8

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