Recommendations for Interchangeability in a Growing Biosimilar Market in Latin America

European Medicines Agency. Guideline on similar biological medicinal products. 2015 [website]. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf. Accessed 27 Apr 2024.

Huang HY, Wu DW, Ma F, Liu ZL, Shi JF, Chen X, et al. Availability of anticancer biosimilars in 40 countries. Lancet Oncol. 2020;21(2):197–201.

Article  PubMed  Google Scholar 

Aguilera B, Peña S, Morales JP. Knowledge, perceptions, and utilization of generics and biosimilars in Latin America and the Caribbean: a scoping review. J Law Med Ethics. 2023;51(S1):100–15.

Article  PubMed  Google Scholar 

Ortiz-Prado E, Izquierdo-Condoy JS, Vasconez-González JE, Dávila G, Correa T, Fernández-Naranjo R. The pharmaceutical market for biological products in Latin America: a comprehensive analysis of regional sales data. J Law Med Ethics. 2023;51(S1):39–61.

Article  PubMed  Google Scholar 

Scheinberg M, Pineda C, Castañeda-Hernández G, Zarbá JJ, Damião A, Arantes LH Jr, et al. Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America. MAbs. 2018;10(6):827–42.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Alnaqbi KA, Bellanger A, Brill A, Castañeda-Hernández G, Clopés Estela A, Delgado Sánchez O, et al. An international comparative analysis and roadmap to sustainable biosimilar markets. Front Pharmacol. 2023;14.

Teran 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(7):e348–58.

Article  PubMed  Google Scholar 

Azevedo VF. Biosimilars require scientifically reliable comparative clinical data. Rev Bras Reumatol. 2013;53:129–31.

PubMed  Google Scholar 

Rathore AS, Stevenson JG, Chhabra H, Maharana C. The global landscape on interchangeability of biosimilars. Expert Opin Biol Ther. 2022;22(2):133–48.

Article  PubMed  Google Scholar 

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

Article  PubMed  PubMed Central  Google Scholar 

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(4):227.

Article  CAS  PubMed  PubMed Central  Google Scholar 

WHO. Guidelines on evaluation of biosimilars. 2021 [website]. https://cdn.who.int/media/docs/default-source/biologicals/who-guidelines-on-evaluation-of-biosimilars---4-nov-2021 Accessed 6 May 2024.

Garcia R, Araujo DV. The regulation of biosimilars in Latin America. Curr Rheumatol Rep. 2016;18:1–8.

Article  Google Scholar 

European Medicines A. Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. 2022.

Barbier L, Mbuaki A, Simoens S, Declerck P, Vulto AG, Huys I. Regulatory information and guidance on biosimilars and their use across Europe: a call for strengthened one voice messaging. Front Med. 2022;9: 820755.

Article  Google Scholar 

European Medicines A. Biosimilars in the EU—Information guide for healthcare professionals: European Commission. 2019. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Accessed 23 Apr 2024.

US Food and Drug Administration.Consideration in demonstrating interchangeabilitywith a reference product. 2019. [website]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-guidance-industry Accessed 6 May 2024.

Alvarez DF, Wolbink G, Cronenberger C, Orazem J, Kay J. Interchangeability of biosimilars: what level of clinical evidence is needed to support the interchangeability designation in the United States? BioDrugs. 2020;34:723–32.

Article  PubMed  PubMed Central  Google Scholar 

IQVIA. The Impact of Biosimilar Competition in Europe. 2021. https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2021.pdf. Accessed 6 May 2024.

Huang H-Y, Liu C-C, Yu Y, Wang L, Wu D-W, Guo L-W, et al. Pharmacoeconomic evaluation of cancer biosimilars worldwide: a systematic review. Front Pharmacol. 2020;11: 572569.

Article  PubMed  PubMed Central  Google Scholar 

Rodriguez G, Mancuso J, Lyman GH, Cardoso F, Nahleh Z, Vose JM, et al. ASCO policy statement on biosimilar and interchangeable products in oncology. JCO Oncol Pract. 2023:OP-22.

GaBI Online. Generics and Biosimilars Initiative: guidelines for the regulation of biologicals, biosimilars and radiopharmaceuticals in Brazil. [website]. www.gabionline.net/guidelines/guidelines-for-the-regulation-of-biologicals-biosimilars-and-radiopharmaceuticals-in-brazil. Accessed 6 May 2024.

Oliveria, Silvia Helena Cestari de. Follow-on biologicals/biosimilars approved in Brazil: May 2023 update. GaBi Journal. 2023; 12.23 [website]. https://gabi-journal.net/category/special-report/issues/volume-12-year-2023-issue-2. Accessed 6 May 2024.

Oliveira SHCD, Alegria MC, Stephano MA. Brazilian regulation of biosimilar products: what is important to know. BioPharm Int. 2022;35(9):30–7.

Google Scholar 

Ministério da Saúde. RESOLUÇÃO DA DIRETORIA COLEGIADA—RDC Nº 55, DE 16 DE DEZEMBRO DE 2010. [website]. 2010 https://antigo.anvisa.gov.br/documents/10181/2718376/%281%29RDC_55_2010_COMP.pdf Accessed 6 May 2024.

Agência Nacional de Vigilância Sanitária. January 2023. 2º Workshop sobre Biológicos e Biossimilares [website]. https://m.youtube.com/watch?v=Zja42cV2XnA. Accessed 6 May 2024.

Subsecretaría de Salud Pública. Registro sanitario de productos biotecnológicos derivados de técnicas ADN recombinantes. 2018 [website]. https://www.bcn.cl/leychile/navegar?idNorma=1116701. Accessed 6 May 2024.

Mysler E, Azevedo VF, Danese S, Alvarez D, Iikuni N, Ingram B, et al. Biosimilar-to-biosimilar switching: what is the rationale and current experience? Drugs. 2021;81(16):1859–79.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Hanzel J, Jansen JM, ter Steege RWF, Gecse KB, D’Haens GR. Multiple switches from the originator infliximab to biosimilars is effective and safe in inflammatory bowel disease: a prospective multicenter cohort study. Inflamm Bowel Dis. 2022;28(4):495–501.

Article  PubMed  Google Scholar 

Gros B, Plevris N, Constantine-Cooke N, Lyons M, O’Hare C, Noble C, et al. Multiple infliximab biosimilar switches appear to be safe and effective in a real-world inflammatory bowel disease cohort. United Eur Gastroenterol J. 2023;11(2):179–88.

Article  CAS  Google Scholar 

Finck B, Geller RB, Walden P. Letter to the Editor regarding “The challenges of switching therapies in an evolving multiple biosimilars landscape: a narrative review of current evidence.” Adv Ther. 2021;38(6):3483–6.

Article  PubMed  PubMed Central  Google Scholar 

Allocati E, Godman B, Gobbi M, Garattini S, Banzi R. Switching among biosimilars: a review of clinical evidence. Front Pharmacol. 2022;13:917814. https://doi.org/10.3389/fphar.2022.917814.

Azevedo VF, Babini A, Caballero-Uribe CV, Castañeda-Hernández G, Borlenghi C, Jones HE. Practical guidance on biosimilars, with a focus on Latin America: what do rheumatologists need to know? J Clin Rheumatol. 2019;25(2):91.

Article  PubMed  Google Scholar 

Ebbers HC, Schellekens H. Are we ready to close the discussion on the interchangeability of biosimilars? Drug Discov Today. 2019;24(10):1963–7.

Article  PubMed  Google Scholar 

Rémuzat C, Dorey J, Cristeau O, Ionescu D, Radière G, Toumi M. Key drivers for market penetration of biosimilars in Europe. J Market Access Health Policy. 2017;5(1):1272308.

Article  Google Scholar 

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.

Article  PubMed  PubMed Central  Google Scholar 

Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19(3):411–9.

Article  CAS  PubMed  Google Scholar 

Dunleavy G. The future of cancer care: health system sustainability in Latin America: Economist Impact. 2023. https://impact.economist.com/perspectives/health/future-cancer-care-LATAM. Accessed 23 Apr 2024.

Mateo J, Steuten L, Aftimos P, André F, Davies M, Garralda E, et al. Delivering precision oncology to patients with cancer. Nat Med. 2022;28(4):658–65.

Article  CAS  PubMed  Google Scholar 

Goss PE, Lee BL, Badovinac-Crnjevic T, Strasser-Weippl K, Chavarri-Guerra Y, St Louis J, et al. Planning cancer control in Latin America and the Caribbean. Lancet Oncol. 2013;14(5):391–436.

Article  PubMed  Google Scholar 

Papadimitropoulos E, Brnabic A, Vorstenbosch E, Leonardi F, Moyano S, Gomez D. The burden of illness of rheumatoid arthritis in Latin America—a systematic literature review. Int J Rheum Dis. 2022;25(4):405–21.

Article  PubMed  Google Scholar 

Gupta R, Singh R, Sharma S, Mishra D, Nagar R, Gupta K. A comprehensive review on biosimilars: the current perspectives and future prospects. Biomed Pharmacother. 2019;109:1616–29.

Google Scholar 

Cohen HP, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs. 2018;78(4):463–78.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Giezen T, Mantel-Teeuwisse A, Jäger A, Leufkens H, van-de Kerkhof P. Dermatologists of the PHARMO Institute. Dynamics of biosimilar entry in EU5 markets. Gener Biosimilars Initiative J (GaBI J). 2017;6(1):29–34.

Gómez R, Meléndez-Rodríguez M, Vásquez-Ríos A. Biosimilars: the Latin American experience. Biologicals. 2020;68:86–91.

Google Scholar 

Kumar D, Singh J, Basu S. Impact of biologic product life cycle and European experience on the regulato

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