Table Info

Table 1.

Examples of follow-on biologics used in rheumatology that are commercialized in Latin America by licensee companies that are not the actual manufacturer

INN	Manufacturer of follow-on biologic (Country)	Local licence (Country)
Rituximab	mAbxience (Argentina)	PiSA-Farmacéutica (Mexico) Laboratorios Bioéticos (Paraguay) Urufarma (Uruguay)
	Celltrion (South Korea)	Saval (Chile)
	AryoGen Pharmed (Iran)	PeruLab (Peru)
Adalimumab	Amgen (USA)	Asofarma (Central America)
Infliximab	Celltrion (South Korea)	Gobbi Novag SA (Argentina) SAVAL Pharmaceuticals (Chile) OXIALFARM CIA LTDA (Ecuador) AC Pharma (Peru)
Etanercept	Shanghai CP Guojian Pharmaceutical Co. Ltd. (China)	Lafrancol (Colombia)

INN: international non-proprietary name

Declarations

Author contributions

GCH: Conceptualization, Visualization, Writing—review & editing. The author read and approved the submitted version.

Conflicts of interest

G.C-H has received consultancy fees from companies commercializing both, originator and biosimilar products, namely AbbVie, Amgen, Asofarma, BeiGene, Merck, Sharp & Dohme, Novartis, Pfizer, Roche, Sandoz, Sanofi, and UCB.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

References

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

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

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/

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. [DOI] [PubMed] [PMC]

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

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. [DOI]

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. [DOI] [PubMed] [PMC]

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. [DOI] [PubMed] [PMC]

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. [DOI] [PubMed] [PMC]

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. [DOI] [PubMed]

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. [DOI] [PubMed] [PMC]

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. [DOI] [PubMed] [PMC]

13.

Kurki P. Copies of Biological Medicines: Similar But Not the Same? BioDrugs. 2023;37:123–6. [DOI] [PubMed] [PMC]

14.

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

15.

McCamish M, Woollett G. Worldwide experience with biosimilar development. MAbs. 2011;3:209–17. [DOI] [PubMed] [PMC]

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. [DOI] [PubMed] [PMC]

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. [DOI] [PubMed] [PMC]

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. [DOI] [PubMed] [PMC]

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. [DOI] [PubMed]

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. [DOI]

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. [DOI]

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_Biotecnol_gicos_Biocomparables__Versi_n_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. [DOI] [PubMed] [PMC]

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. [DOI] [PubMed]

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. [DOI] [PubMed] [PMC]

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