Assessing pharmacists’ knowledge and perceptions of biosimilars: A cross-sectional study in Argentina
DOI:
https://doi.org/10.46542/pe.2025.251.467477Keywords:
Biosimilar, Biosimilar substitution, Knowledge, Medicine access, Pharmacist, SurveyAbstract
Background: As biosimilars become more widely used globally, pharmacists’ knowledge and attitudes are pivotal to safe utilisation, substitution policies, and pharmacovigilance. This study assessed Argentinian pharmacists’ knowledge and perceptions of biosimilars.
Methods: A cross-sectional study was conducted between 26 August and 30 November 2023. An anonymous, validated, online questionnaire, comprising 18 questions across three sections, was administered to pharmacists of all specialties in Argentina.
Results: Responses were received from 502 pharmacists; 75% had over six years’ experience and 69% worked in community or hospital settings. Approximately half of the respondents demonstrated adequate knowledge (67% of correct answers). Topic-specific correctness was higher for bioequivalence (79%) and preclinical/clinical trials (83%) and lower for pharmacovigilance (43%). Most participants supported biosimilars’ market entry (72%) and viewed local regulatory implementation as fundamental (84%), yet about half were unaware of current regulations. Only 16% had received adverse-event reports and 18% favoured pharmacist-led substitution. The need for further training was strongly endorsed (83%).
Conclusion: Despite supportive attitudes and moderate knowledge, gaps persist in regulatory awareness, interchangeability, and pharmacovigilance. Targeted education and clearer national guidance are warranted to strengthen safe and effective biosimilar use and substitution.
References
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). (2025). Guía de comparabilidad de Biosimilares Disposición 7014/2025. Accessed May 25, 2025. https://www.boletinoficial.gob.ar/detalleAviso/primera/322607/20250317
Aguilera B., Peña S., Morales J.P. (2023). Knowledge, perceptions, and utilization of generics and biosimilars in Latin America and the Caribbean: A scoping review. The Journal of Law, Medicine & Ethics, 51(S1), 100–115. https://doi.org/10.1017/jme.2023.117
APhA (American Pharmacists Association). (2024). Interchangeable biosimilars: pharmacist’s guide to frequently asked questions. Accessed May 25, 2025. https://www.pharmacist.com/Advocacy/Issues/Biosimilars/Biologics-and-Biosimilar-Drug-Products-Pharmacist-Guide-to-Patients-Frequently-Asked-
Armando, P. D., Uema, S. A., & Vega, E. M. (2020). Integration of Community pharmacy and pharmacists in primary health care policies in Argentina. Pharmacy Practice (Granada), 18(4), 2173. https://dx.doi.org/10.18549/pharmpract.2020.4.2173
Awada, S., Sayah, R., Mansour, M., Nabhane, C., & Hatem, G. (2023). Assessment of community pharmacists' knowledge of the differences between generic drugs and biosimilars: A pilot cross-sectional study. Journal of Medical Access, 7, 27550834231167049. https://doi.org/10.1177/27550834231167049
Bas, T. (2016). Biosimilars in two developing economies of South America (Argentina and Brazil) and one developed economy of Oceania (Australia). Facts, regulations, and evolution. Research Journal of Pharmaceutical, Biological and Chemical Sciences, 7, 1794–1809. https://www.rjpbcs.com/pdf/2016_7(5)/[228].pdf
Bates, I., John, C., Bruno, A., Fu, P., & Aliabadi, S. (2016). An analysis of the global pharmacy workforce capacity. Human Resources for Health, 14(1), 61. https://doi.org/10.1186/s12960-016-0158-z
BioSIM, Asociación Española de Biosimilares. (2019). GUÍA DE MEDICAMENTOS Biosimilares para farmacéuticos. Accessed May 25, 2025. https://www.sefac.org/sites/default/files/2019-03/GUIA-BIOSIMILARES-FARMACEUTICOS.pdf
Castañeda-Hernández, G., Sandoval, H., Coindreau, J., Rodriguez-Davison, L. F., & Pineda, C. (2019). Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey. Pharmacoepidemiology and Drug Safety, 28, 1035–1044. https://doi.org/10.1002/pds.4785
da Silva Machado, F. L., Cañás, M., Urtasun, M. A., Marin, G. H., Albuquerque, F. C., Pont, L., Convertino, I., Bonaso, M., Tuccori, M., Kirchmayer, U., & Cruz Lopes L. (2024). A cross-national comparison of biosimilars pricing in Argentina, Australia, Brazil, and Italy. Therapeutic Innovation & Regulatory Science, 58, 549–556. https://doi.org/10.1007/s43441-024-00623-8
Endrenyi, L., & Markus, R. (2019). Interchangeability of biological drug products-FDA draft guidance. Journal of Biopharmaceutical Statistics, 29(6), 1003–1010. https://doi.org/10.1080/10543406.2019.1607369
Eppes, C., Wu, A., You, W., Cameron, K. A., Garcia, P., & Grobman, W. (2013). Barriers to influenza vaccination among pregnant women. Vaccine, 31(27), 2874–2878. https://doi.org/10.1016/j.vaccine.2013.04.031
Farhat, F., Othman, A., El Karak, F., & Kattan, J. (2016). Review and results of a survey about biosimilars prescription and challenges in the Middle East and North Africa region. SpringerPlus, 5(1), 2113. https://doi.org/10.1186/s40064-016-3779-8
Gasteiger, C., Gasteiger, N., & Petrie, K. J. (2022). Pharmacists' confidence in explaining biosimilars to patients before a nationwide medicine change: A cross-sectional study. Exploratory Research in Clinical and Social Pharmacy, 8, 100199. https://doi.org/10.1016/j.rcsop.2022.100199
Gibofsky, A., Evans, C., & Strand, V. (2022). Provider and patient knowledge gaps on biosimilars: Insights from surveys. American Journal of Managed Care, 28(12 Suppl), S227–S233. https://doi.org/10.37765/ajmc.2022.89297
Goecke, A., Trigueros, P. D., Vargas, A., Babini, A., Graf, C., Provenza, J. R., Ferreira, W. H., Andrade, A., Gimenez, M., & Cabrera, E. (2020). The patients' knowledge and perception about biologics and biosimilars: Results of a survey at the South Cone Zone of Panlar. JCR-journal of Clinical Rheumatology, 26(3), 107–108. https://repositorio.uchile.cl/handle/2250/175268
Heffernan, M. E., & Macy, M. L. (2025). Survey response rates: Reassessing expectations. Journal of the Pediatric Infectious Diseases Society, 14(5), piaf031. https://doi.org/10.1093/jpids/piaf031
Jarab, A. S., Al-Qerem, W., Alzoubi, K. H., Abu Heshmeh, S. R., Al Hamarneh, Y. N., Alefishat, E., & Aburuz, S. (2025). Understanding community pharmacists’ knowledge, attitudes, and practices regarding biosimilar drugs: A cross-sectional survey. International Journal of Clinical Practice, 2025(1), 2248512. https://doi.org/10.1155/ijcp/2248512
Kolbe, A. R., Kearsley, A., Merchant, L., Temkin, E, Patel, A., Xu, J., & Jessup Amber. (2021). Physician understanding and willingness to prescribe biosimilars: Findings from a US national survey. BioDrugs, 35, 363–372. https://doi.org/10.1007/s40259-021-00479-6
Li, E., Liu, J., & Ramchandani, M. A. (2017). Framework for integrating biosimilars into the didactic core requirements of a Doctor of Pharmacy curriculum. American Journal of Pharmaceutical Education, 81(3), 57. https://doi.org/10.5688/ajpe81357
Marín-Jiménez, I., Carrascosa, J. M., Guigini, M. A., & Monte-Boquet, E. (2021). Knowledge, perceptions, attitude, barriers and facilitators of biosimilars use across specialty physicians and hospital pharmacists: A national survey. Farmacia Hospitalaria, 45(5), 240–246. https://www.revistafarmaciahospitalaria.es/es-pdf-S1130634323005299
Meara, K. (2024). Pharmacist education, knowledge key to fostering biosimilar adoption. Drug Topics Journal, 168(02). https://www.drugtopics.com/view/pharmacist-education-knowledge-key-to-fostering-biosimilar-adoption
Menon, V., & Muraleedharan, A. (2020). Internet-based surveys: relevance, methodological considerations and troubleshooting strategies. General Psychiatry, 33(5), e100264. https://doi.org/10.1136/gpsych-2020-100264
Merino, Á. (2020). ¿Cuántos farmacéuticos hay en el mundo? El Orden Mundial (EOM). https://elordenmundial.com/mapas-y-graficos/cuantos-farmaceuticos-hay-mundo/
Messner, K., Eickhoff, C., Schulz, M., Allemann, S. S., & Arnet, I. (2023). Knowledge and attitudes of German and Swiss community pharmacists towards biologicals and biosimilars – a prospective survey before and after the COVID-19 pandemic. BMC Health Services Research, 23, 1432. https://doi.org/10.1186/s12913-023-10475-x
Minitab, LLC. (2019). Minitab. https://www.minitab.com
O'Callaghan, J., Bermingham, M., Leonard, M., Hallinan, F., Morris, J. M., Moore, U., & Griffin, B. T. (2017). Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland. Regulatory Toxicology and Pharmacology, 88, 252–261. https://doi.org/10.1016/j.yrtph.2017.06.013
Oqal, M., Hijazi, B., Alqudah, A., Al-Smadi, A., Almomani, B., Alnajjar, R., Ghunaim, M., Irshaid, M., & Husam, A. (2022). Awareness and knowledge of pharmacists toward biosimilar medicines: A survey in Jordan. International Journal of Clinical Practice, 27, 8080308. https://doi.org/10.1155/2022/8080308
Ortiz-Prado, E., Izquierdo-Condoy, J. S., Vasconez-González, J. E., Dávila, G., Correa, T., & Fernández-Naranjo, R. (2023). The pharmaceutical market for biological products in Latin America: A comprehensive analysis of regional sales data. Journal of Law, Medicine & Ethics, 51(S1), 39–61. https://doi.org/10.1017/jme.2023.112
Pawłowska, I., Pawłowski, L., Krzyżaniak, N., & Kocić, I. (2019). Perspectives of hospital pharmacists towards biosimilar medicines: A survey of Polish pharmacy practice in general hospitals. BioDrugs, 33, 183–191. https://doi.org/10.1007/s40259-019-00341-w
Raosoft Inc. (2004). Raosoft Sample Size Calculator. Seattle, USA. http://www.raosoft.com/samplesize.html
Reilly, M. S., &. Gewanter, H. L. (2015). Prescribing practices for biosimilars: Questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico. Generics and Biosimilars Initiative Journal, 4, 161–167. https://doi.org/10.5639/gabij.2015.0404.036
Rieger, C., Dean, J. A., Hall, L., Vazquez, P., Merlo, G. (2024). Barriers and enablers affecting the uptake of biosimilar medicines viewed through the lens of actor network theory: A systematic review. BioDrugs, 38, 541–555. https://doi.org/10.1007/s40259-024-00659-0
Sarnola, K., Merikoski, M., Jyrkkä, J., & Hämeen-Anttila, K. (2020). Physicians' perceptions of the uptake of biosimilars: a systematic review. BMJ Open, 10(5), e034183. https://doi.org/10.1136/bmjopen-2019-034183
Sharma, A., Minh Duc, N. T., Luu Lam Thang, T., Nam, N. H., Ng, S. J., Abbas, K. S., Huy, N. T., Marušić, A., Paul, C. L., Kwok, J., Karbwang, J., de Waure, C., Drummond, F. J., Kizawa, Y., Taal, E., Vermeulen, J., Lee, G. H. M., Gyedu, A., To, K. G., Verra, M. L., Jacqz-Aigrain, É. M., Leclercq, W. K. G., Salminen, S. T., Sherbourne, C. D., Mintzes, B., Lozano, S., Tran, U. S., Matsui, M., & Karamouzian, M. (2021). A consensus-based checklist for reporting of survey studies (CROSS). Journal of General Internal Medicine, 36(10), 3179–3187. https://doi.org/10.1007/s11606-021-06737-1
Shubow, S., Sun, Q., Nguyen Phan, A. L., Hammell, D. C., Kane, M., Lyman, G. H., Gibofsky, A., Lichtenstein, G. R., Bloomgarden, Z., Cross, R. K., Yim, S., Polli, J. E., & Wang, Y. M. (2023). Prescriber perspectives on biosimilar adoption and potential role of clinical pharmacology: A workshop summary. Clinical Pharmacology & Therapeutics, 113(1), 37–49. https://doi.org/10.1002/cpt.2765
Sociedad Argentina de Dermatología (SAD). (2018). COMUNICADO | Declaración de la SAD sobre medicamentos de origen biológico. Otra Medicina, 78, 272–281. https://sad.org.ar/comunicado-declaracion-de-la-sad-sobre-medicamentos-de-origen-biologico/
Stevenson, J. G., McCabe, D., McGrath, M., & McBride, A. (2023). Pharmacist biosimilar survey reveals knowledge gaps. Journal of the American Pharmacists Association, 63(2), 529–537.e7. https://doi.org/10.1016/j.japh.2022.11.001
WHO Expert Committee on Biological Standardization. (2022). Annex 3: Guidelines on evaluation of biosimilars. Replacement of Annex 2 of WHO Technical Report Series, No. 977. Retrieved February 24, 2023, from https://cdn.who.int/media/docs/default-source/biologicals/who_trs_1043_annex-3_biosimilars_tk.pdf
Zuñiga, L., & Calvo, B. (2010). Biosimilars: pharmacovigilance and risk management. Pharmacoepidemiology and Drug Safety, 19(7), 661–669. https://doi.org/10.1002/pds.1948
