Selecting the best-value biosimilar in emerging countries

Abstract

The aim of biosimilars is to alleviate the financial burden of biological medicinal products. A most relevant challenge for emerging countries is how to select the best option available. In most cases, price is the major determinant, as budgets are chronically scarce. However, initial savings due to price reductions can be overridden if there is a lack of supply due to product shortages or withdrawals. These events can be prevented by a best-value strategy. According to the concept of best-value medicinal products, price is only one of the various criteria to be considered. The purpose of the present paper is to provide suggestions of criteria that can be useful for selecting the best-value biological in emerging countries. Six criteria, that are not limitative, have been selected as follows: standards of regulatory approval, quality of the product, good distribution practices, security of supply, pharmacovigilance, and price.

Keywords

Biosimilars / best-value / emerging countries / follow-on biologics

References

[1] Biosimilars in the EU-Information guide for healthcare professionals [Internet]. Amsterdam: European Medicines Agency; c2019 [cited 2024 Jul 10]. Available from: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf

[2] Biological Product Definitions [Internet]. US Food and Drug Administration; [cited 2024 Jul 10]. Available from: https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf

[3] Guidelines on evaluation of biosimilars [Internet]. WHO; c2024 [cited 2024 Jul 10]. Available from: https://www.who.int/publications/m/item/guidelines-on-evaluation-of-biosimilars/

[4] Alnaqbi KA, Bellanger A, Brill A, Castañeda-Hernández G, Estela AC, Sánchez OD, et al. An international comparative analysis and roadmap to sustainable biosimilar markets. Front Pharmacol. 2023; 14: 1188368.

[5] Rathore AS, Stevenson JG, Chhabra H, Maharana C. The global landscape on interchangeability of biosimilars. Expert Opin Biol Ther. 2022; 22: 133-48.

[6] Boone N, van der Kuy H, Scott M, Mairs J, Kramer I, Vulto A, et al. How to select a biosimilar. Eur J Hosp Pharm. 2013; 20: 275-86.

[7] Klein K, Gencoglu M, Heisterberg J, Acha V, Stolk P. The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries. BioDrugs. 2023; 37: 235-45.

[8] Feng K, Russo M, Maini L, Kesselheim AS, Rome BN. Patient Out-of-Pocket Costs for Biologic Drugs After Biosimilar Competition. JAMA Health Forum. 2024; 5: e235429.

[9] Barbier L, Vandenplas Y, Boone N, Huys I, Janknegt R, Vulto AG. How to select a best-value biological medicine? A practical model to support hospital pharmacists. Am J Health Syst Pharm. 2022; 79: 2001-11.

[10] Duggan B, Smith A, Barry M. Uptake of biosimilars for TNF-α inhibitors adalimumab and etanercept following the best-value biological medicine initiative in Ireland. Int J Clin Pharm. 2021; 43: 1251-6.

[11] Lacosta TB, Vulto AG, Huys I, Simoens S. An exploration of biosimilar TNF-alpha inhibitors uptake determinants in hospital environments in Italy, Portugal, and Spain. Front Med (Lausanne). 2023; 9: 1029040.

[12] Peng K, Blais JE, Pratt NL, Guo JJ, Hillen JB, Stanford T, et al. Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis. BioDrugs. 2023; 37: 409-20.

[13] Kurki P. Copies of Biological Medicines: Similar But Not the Same? BioDrugs. 2023; 37: 123-6.

[14] González-Ramírez R, Castañeda-Hernández G. The challenges of developing and commercializing biosimilars in Latin America. Pharm Pat Anal. 2019; 8: 221-4.

[15] McCamish M, Woollett G. Worldwide experience with biosimilar development. MAbs. 2011; 3: 209-17.

[16] Hassett B, Scheinberg M, Castañeda-Hernández G, Li M, Rao URK, Singh E, et al. Variability of intended copies for etanercept (Enbrel^®): Data on multiple batches of seven products. MAbs. 2018; 10: 166-76.

[17] Good distribution practice [Internet]. Amsterdam: European Medicines Agency; c1995-2024 [cited 2024 Jul 10]. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/good-distribution-practice/

[18] Yu YB, Briggs KT, Taraban MB, Brinson RG, Marino JP. Grand Challenges in Pharmaceutical Research Series: Ridding the Cold Chain for Biologics. Pharm Res. 2021; 38: 3-7.

[19] Dranitsaris G, Jacobs I, Kirchhoff C, Popovian R, Shane LG. Drug tendering: drug supply and shortage implications for the uptake of biosimilars. Clinicoecon Outcomes Res. 2017; 9: 573-84.

[20] Basu S, Yudkin JS, Kehlenbrink S, Davies JI, Wild SH, Lipska KJ, et al. Estimation of global insulin use for type 2 diabetes, 2018-30: a microsimulation analysis. Lancet Diabetes Endocrinol. 2019; 7: 25-33.

[21] Odhaib SA, Masood SN, Shegem N, Khalifa SF, Abi Saad M, Eltom M, et al. The status of insulin access in Middle East-North Africa region. J Diabetol. 2022; 13: S48-61.

[22] Huerta-Sánchez OM, Aguilar-Ponce JL, Meneses-García A, Herrera-Gómez Á, Herrera-Hernández R, Monroy-Cruz MT, et al. Implementation of a robust pharmacovigilance method for filgrastim non-innovator products in cancer patients in routine clinical practice complying with Mexican regulation for biocomparables. J Pharmacovigil. 2015; 3: 1-6.

[23] Medicamentos biotecnológicos biocomparables Versión 08 [Internet]. COFEPRIS; [cited 2024 Jul 10]. Available from: https://www.gob.mx/cms/uploads/attachment/file/923118/Listado_de_Medicamentos_Biotecnologicos_Biocomparables__Version_8__05-2024.pdf

[24] Oza B, Radhakrishna S, Pipalava P, Jose V. Pharmacovigilance of biosimilars-Why is it different from generics and innovator biologics? J Postgrad Med. 2019; 65: 227-32.

[25] Terán E, Gomez H, Hannois D, Lema M, Mantilla W, Rico-Restrepo M, et al. Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective. Lancet Oncol. 2022; 23: e348-58.

[26] Castañeda-Hernández G, Sandoval H, Coindreau J, Rodríguez-Davison LF, Pineda C. Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey. Pharmacoepidemiol Drug Saf. 2019; 28: 1035-44.

[27] La COFEPRIS revoca registro del producto “kikuzubam” [Internet]. COFEPRIS; [cited 2024 Jul 10]. Available from: https://www.gob.mx/cms/uploads/attachment/file/127522/2_Alerta_sanitaria_KIKUZUBAM_28032014.pdf