{"id":158979,"date":"2025-04-16T22:45:07","date_gmt":"2025-04-16T20:45:07","guid":{"rendered":"https:\/\/efecomunica.efe.com\/?p=158979"},"modified":"2025-04-16T23:28:18","modified_gmt":"2025-04-16T21:28:18","slug":"biosidus-announces-promising-interim-results-from-phase-iii-study-on-agalsidase-beta-for-fabry-disease","status":"publish","type":"post","link":"https:\/\/efecomunica.efe.com\/en\/biosidus-announces-promising-interim-results-from-phase-iii-study-on-agalsidase-beta-for-fabry-disease\/","title":{"rendered":"Biosidus announces promising Interim results from Phase III Study on Agalsidase Beta for Fabry Disease"},"content":{"rendered":"
\n

Statement issued by the company (Announcement)<\/span><\/p>\n

Biosidus<\/a>, an Argentinean pioneer company in biotechnology research, development, and the production of high-quality biosimilars, has announced encouraging <\/strong>interim results<\/strong> from the Phase III SMILE1<\/sup> study. After 26 weeks of treatment, the study successfully met its primary endpoint, underscoring the potential of agalsidase beta as a safe and effective biosimilar treatment<\/strong> for Fabry disease. The complete dataset, including final secondary objectives, is expected to be published by the first semester of 2025 and commercialization in Argentina could begin by the middle of this year.<\/p>\n

\u201cThere are currently only two biosimilars of this product available worldwide, and we will have the first one in Argentina and the region,\u201d\u00a0<\/em>says Mario Koch, Commercial Operations Director for Southern Latam at Biosidus. \u201cOur product is already approved in Argentina, but once we obtain local authorization to launch, we plan to expand to other countries. Our roadmap for the next two to four years includes strategic entry into emerging markets where Biosidus has established partnerships, with a long-term goal of reaching Europe and the United States. Our vision is to take this product from Argentina to the world<\/em>.\u201d<\/p>\n

A rigorous preclinical trial program confirmed a high degree of similarity with the reference product in all analyzed physicochemical and biological properties2<\/sup>. Likewise, the data collected suggest that its pharmacokinetic, pharmacodynamic, immunogenic, and safety profiles could be comparable to the innovative product3<\/sup>. Safety data collected so far in the SMILE study, continue to support the potential of our drug to become a biosimilar treatment for Fabry disease. \u201cThis study was designed to scientifically assess the comparability of our drug with the reference innovator drug, analyzing its behavior as a biosimilar,\u201d<\/em>\u00a0emphasizes Dr. Viridiana Berstein, Clinical Research Manager at Biosidus<\/a>.<\/p>\n

Treatments for Fabry disease are considered high-cost, often posing a challenge to the sustainability of healthcare systems and equitable access, particularly in emerging countries. \u201cThe cost reduction from a biosimilar product, especially for a lifelong treatment, will definitely contribute to the sustainability of the system, probably reducing legal disputes and enabling access to a larger number of patients<\/em>,\u201d concludes Koch.<\/p>\n

Biosidus\u2019 commitment to global biosimilar access<\/u><\/strong>
\nWith over 40 years of experience in the development, production, and commercialization of biosimilars, Biosidus<\/a> remains dedicated to improving global access to high-quality treatments. Its portfolio of nine self-developed products is already exported to more than 50 countries.<\/p>\n

Given the significant financial burden that rare disease treatments place on healthcare systems, biosimilars present a viable solution for making therapies more affordable and accessible. Currently, seven countries account for 85% of the global consumption of biologics. Biosidus is committed to narrowing this gap through an ethical and equitable approach to biosimilar distribution.<\/p>\n

For more information about Biosidus: https:\/\/www.biosidus.com.ar\/en\/<\/a><\/p>\n

Media Contact:\r\nMariela de la Fuente\r\n+54 11 6529-3052\r\ndireccioncuentas@paradigmapel.com<\/a><\/pre>\n
______________________________<\/em><\/strong><\/sup><\/p>\n
1<\/em><\/sup>Switch Over Study of Biosimilar AGA for\u00a0Fabry\u00a0Disease\u00a0(SMILE). ClinicalTrials.gov ID NCT05843916<\/em>
\n<\/em><\/strong>2<\/em><\/sup> Van <\/em>Kuilenburg<\/em>, Hollak et al. Development of a Biosimilar of Agalsidase Beta for the Treatment of Fabry Disease: Preclinical Evaluation. <\/em>Drugs<\/em> R D. 2023 Jun;23(2):141-153. Disponible en:
\n<\/em>https:\/\/www.researchgate.net\/publication\/370182850_Development_of_a_Biosimilar_of_Agalsidase_Beta_for_the_Treatment_of_Fabry_Disease_Preclinical_Evaluation
\n<\/a><\/em>3<\/em><\/sup> Berstein et al. Comparative pharmacokinetics and pharmacodynamics of two formulations of agalsidase beta. Mol Genet <\/em>Metab<\/em> Rep. 2024 Oct 7:41:101149. Available at: <\/em>https:\/\/www.sciencedirect.com\/science\/article\/pii\/S2214426924001022<\/em><\/a><\/sub><\/p>\n
AGENCIA EFE S.A.U.,S.M.E. shall not be liable for any information contained in this message and assumes no responsibility towards third parties in relation to its contents, being expressly exempt from any liability that the author may have in relation to the information in question. Agencia EFE reserves the right to distribute the press release on the news wire, or to publish it on EFE Comunica.<\/span><\/i><\/p>\n

\n<\/p>\n<\/div>\n
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Statement issued by the company (Announcement) Biosidus, an Argentinean pioneer company in biotechnology research, development, and the production of high-quality biosimilars, has announced encouraging interim results from the Phase III […]<\/p>\n","protected":false},"author":198164071,"featured_media":48434,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[121851],"tags":[],"class_list":["post-158979","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"acf":[],"yoast_head":"\nBiosidus announces promising Interim results from Phase 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