دورية أكاديمية

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America.

التفاصيل البيبلوغرافية
العنوان: Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America.
المؤلفون: Scheinberg M; a Rheumatology Section - Orthopedics Department , Hospital Israelita Albert Einstein , São Paulo , Brazil., Pineda C; b Division of Musculoskeletal and Rheumatic Diseases , Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra , Mexico City , Mexico., Castañeda-Hernández G; c Department of Pharmacology , Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional , Mexico City , Mexico., Zarbá JJ; d Oncology Department , Hospital Centro de Salud Zenón J. Santillán , San Miguel de Tucumán , Argentina.; e Facultad de Medicina, Universidad Nacional de Tucumán , San Miguel de Tucumán , Argentina., Damião A; f Department of Gastroenterology , University of São Paulo Medical School , São Paulo , Brazil., Arantes LH Jr; g Pfizer Inc , New York , NY , USA., Jacobs I; g Pfizer Inc , New York , NY , USA.
المصدر: MAbs [MAbs] 2018 Aug/Sep; Vol. 10 (6), pp. 827-842. Date of Electronic Publication: 2018 Aug 29.
نوع المنشور: Journal Article; Review
اللغة: English
بيانات الدورية: Publisher: Taylor & Francis Country of Publication: United States NLM ID: 101479829 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1942-0870 (Electronic) Linking ISSN: 19420862 NLM ISO Abbreviation: MAbs Subsets: MEDLINE
أسماء مطبوعة: Publication: 2015- : Philadelphia, PA : Taylor & Francis
Original Publication: Austin, TX : Landes Bioscience
مواضيع طبية MeSH: Antibodies, Monoclonal/*therapeutic use , Biological Products/*therapeutic use , Biosimilar Pharmaceuticals/*therapeutic use , Inflammation/*drug therapy , Neoplasms/*drug therapy, Drug Approval/methods ; Drug Therapy/methods ; Drug Therapy/trends ; Forecasting ; Humans ; Inflammation/immunology ; Latin America ; Neoplasms/immunology
مستخلص: Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patient access to biologics. In Latin American countries, regulatory frameworks for biosimilar approval have been introduced in recent years, and biosimilars of monoclonal antibody and fusion protein therapies are now emerging. However, the situation in this region is complicated by the presence of "non-comparable biotherapeutics" (also known as "intended copies"), which have not been rigorously compared with the originator product. We review the considerations for clinicians in Latin American countries, focusing on monoclonal antibody biosimilars relevant to oncology, rheumatology, gastroenterology, and dermatology.
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فهرسة مساهمة: Keywords: Antibodies; Latin America; biological therapy; biosimilar pharmaceuticals; dermatology; gastroenterology; monoclonal; neoplasms; rheumatology
المشرفين على المادة: 0 (Antibodies, Monoclonal)
0 (Biological Products)
0 (Biosimilar Pharmaceuticals)
تواريخ الأحداث: Date Created: 20180830 Date Completed: 20190225 Latest Revision: 20230928
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC6152448
DOI: 10.1080/19420862.2018.1484977
PMID: 30156950
قاعدة البيانات: MEDLINE
الوصف
تدمد:1942-0870
DOI:10.1080/19420862.2018.1484977