Researchers from Brazil investigated, from a pharmaceutical perspective, a major problem of the present time, which is the interchangeability of biosimilars [1].
Biosimilars used in the treatment of cancer are presented as an opportunity to reduce costs in cancer treatment and increase competition in the market for biologicals, allowing patients access to the treatment they need. In addition, they make it possible to change the therapeutic scenario of cancer patients.
To this end, the authors therefore carried out a literature review using the descriptors ‘biosimilar’, ‘oncology therapy’, ‘interchangeable drugs’ and ‘biological products’, in the ScienceDirect, MEDLINE and CAPLUS databases. From this search, 51 articles were selected, which addressed the importance of establishing standards that demonstrate the efficacy and safety of biosimilars with reference products, as well as the growing interest of the pharmaceutical industry in the development of biosimilars and the impact on costs and changes in the perspective of the treatment of cancer patients.
As patents expire, there is the possibility of developing biosimilars. However, these products are unlike generics, as they are large and complex molecules. It is therefore impossible to obtain identical copies of their reference products, which generates conflicts and concerns on the part of the pharmaceutical class regarding the safety of the interchangeability of these products.
The authors found that since biosimilars were approved for commercialization, there is still no global consensus on the best way to compare biosimilars with their reference products. They also found that some drug regulatory agencies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Brazil’s ANVISA (Agência Nacional de Vigilância Sanitária), allow the interchangeability of biosimilars as long as they present biological activity studies that demonstrate that their effectiveness is similar to their reference product.
The authors concluded that it is important that the pharmaceutical professional evaluate their commercial use through pharmacovigilance, assessing the risk-benefit of the interchangeability of these products.
Conflict of interest
The authors of the research paper [1] did not provide any conflict of interest statement.
Abstracted by Iago Dillion Lima Cavalcanti, Master in Pharmaceutical Sciences, Specialist in Cancer Care and Palliative Care, Department of Biological Sciences – Universidade Federal de Pernambuco – UFPE, Recife, Brazil.
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety, and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that non-originator biologicals approved only outside of Europe might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
Readers interested to learn more about the interchangeability of biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Interchangeability of biosimilars in the US and around the world
USA and Europe differ in interchangeability of biosimilars
GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.
GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
1.9 – CiteScoreTracker 2021 (Last updated on 4 August 2021)
Submit a manuscript to GaBI Journal
Related articles
Different approaches to the interchangeability of biosimilars
Interchangeability of biosimilars around the world
| LATIN AMERICAN FORUM The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Biosimilares e intercambiabilidad en oncología Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Biosimilares e intercambiabilidad en oncología Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
|
Reference
1. Santos Soares JC, Cavalcanti IDL, de Albuquerque Vasconcelos JL. Can biosimilar products be interchangeable? Pharmaceutical perspective in the implementation of biosimilars in oncology. J Oncol Pharm Pract. May 2021. doi:10.1177/10781552211016099
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment