Biosimilars are medicines produced according to the quality, efficacy, and safety requirements of industry regulatory agencies, created after the patent for the original, innovative medicine has expired. Over the last decade, there has been a continuous and growing increase in the number of these biosimilars for different therapeutic indications. A recent study coordinated by the University of La Laguna analyzed three biosimilars of the colon cancer treatment bevacizumab, finding that they meet the established criteria for the content of this substance, but not for the dimer (composite protein) of the originally patented medicine.<\/p>\n
The study<\/a> It has recently been published in the magazine Pharmaceuticals<\/em> with Alexis Oliva<\/a>, from the Department of Chemical Engineering and Pharmaceutical Technology at the University of La Laguna, as the lead author. A multidisciplinary group of researchers participated in the study, including Adrian Conde<\/a>, from the Department of Chemistry; Magnalena Echezarreta<\/a>, from the Department of Chemical Engineering and Pharmaceutical Technology; and \u00c1lvaro Santana, from the General Research Support Service of the Tenerife institution. International collaboration was also secured from SC Chow, of Duke University in North Carolina (USA), former FDA advisor on biosimilar interchangeability; and Joao Conc\u00e0lves, from the Faculty of Pharmacy at the University of Lisbon, a European expert in the clinical analysis of biosimilars.<\/p>\n In this work, several batches of the reference product bevacizumab (Avastin\u00ae), a monoclonal antibody used in the treatment of colon cancer, were analyzed, and three biosimilars marketed since 2021 in Spain: Alymsys\u00ae, Oyavas\u00ae and Vegzelma\u00ae.<\/p>\n The proliferation of biosimilars is largely due to their lower prices, which reduce costs for patients and healthcare systems, thereby increasing access to effective therapies. Their manufacture is a complex process, sensitive to variations in the production process at different stages, resulting in heterogeneous products. However, it is a controlled and reproducible process that yields a product that meets quality specifications.<\/p>\n Therefore, analytical similarity assessment is one of the critical steps for the successful development of biosimilars, and manufacturers need to know the criteria to ensure the efficacy, safety, and quality of the proposed product. Various regulatory agencies, such as the European EMA, the US FDA, the World Health Organization (WHO), and the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), have outlined and regulated similarity acceptance criteria for biosimilar approval.<\/p>\n Analysis of bevacizumab<\/strong><\/p>\n For the study, the quality attributes used were dimer content, which is indicative of the aggregation process (an aspect that must be monitored throughout the life cycle of any biological product and is relevant in the case of bevacizumab) and drug concentration, since biosimilars must provide the same dose as the reference product.<\/p>\n In the first phase, ten batches of Avastin\u00ae were analyzed over a 10-year period to verify the consistency of the manufacturing process and determine whether it maintained the required quality standards. To this end, expected \u03b2-tolerance intervals were calculated using variance components to account for both batch-to-batch and batch-to-batch variability. Additionally, a process capability analysis was performed using a capability index called Cpk.<\/p>\n The results obtained confirm that the manufacturing process of the reference product is under statistical quality control during the analyzed period and that the bevacizumab content meets the product specification limits. In contrast, the three biosimilars analyzed meet the established criteria for bevacizumab content, but not for dimer content.<\/p>\n These differences can be attributed to the production design implemented for each biosimilar. It is important to note that two of these biosimilars are produced by the same manufacturer but marketed in Spain by two different companies, so the observed differences may originate from distribution or storage conditions.<\/p>\n In a second stage, analytical similarity was assessed using two quality interval (QR)-based methods: the QR method, proposed by the FDA, and the maximum likelihood quality interval method (QRML), proposed by Professors Oliva and Llabr\u00e9s in 2021. The calculated quality intervals were very similar, although those estimated by the QRML method were more precise. This study demonstrated that the three biosimilar products are highly similar to the original in terms of drug concentration, regardless of the method used, while for dimer content, this was only demonstrated for the first biosimilar.<\/p>\n The research team's next objective is to evaluate the consistency of the manufacturing process of the different biosimilars by applying the same methodology and to confirm the results on analytical similarity, using other quality attributes, especially those related to the structural and functional evaluation of proteins.<\/p>","protected":false},"excerpt":{"rendered":" Biosimilars are medicines produced in accordance with the requirements of the sector's regulatory agencies regarding quality, efficacy\u2026<\/p>","protected":false},"author":15,"featured_media":575,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[35,6,177,20,357,37,348,10,39],"tags":[358,359,360,361,362],"class_list":["post-574","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-departamentos","category-destacado","category-facultad-de-ciencias-facultades-y-escuelas","category-facultades-y-escuelas","category-ingenieria-quimica-y-tecnologia-farmaceutica","category-investigacion","category-noticias-segai","category-portada-ull","category-servicios","tag-alexis-oliva","tag-bevacizumab","tag-biosimilares","tag-cancer-de-colon","tag-carolina-echezarreta"],"acf":[],"primary_category":null,"featured_image_thumbnail_url":"https:\/\/www.ull.es\/portal\/noticias\/wp-content\/uploads\/sites\/2\/2026\/10\/pildora-300x200.jpg","_links":{"self":[{"href":"https:\/\/www.ull.es\/portal\/noticias\/en\/wp-json\/wp\/v2\/posts\/574","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.ull.es\/portal\/noticias\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.ull.es\/portal\/noticias\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.ull.es\/portal\/noticias\/en\/wp-json\/wp\/v2\/users\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ull.es\/portal\/noticias\/en\/wp-json\/wp\/v2\/comments?post=574"}],"version-history":[{"count":0,"href":"https:\/\/www.ull.es\/portal\/noticias\/en\/wp-json\/wp\/v2\/posts\/574\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.ull.es\/portal\/noticias\/en\/wp-json\/wp\/v2\/media\/575"}],"wp:attachment":[{"href":"https:\/\/www.ull.es\/portal\/noticias\/en\/wp-json\/wp\/v2\/media?parent=574"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ull.es\/portal\/noticias\/en\/wp-json\/wp\/v2\/categories?post=574"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ull.es\/portal\/noticias\/en\/wp-json\/wp\/v2\/tags?post=574"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}