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Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
ABSTRACT Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or referenceExpand
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Comparative functional and pharmacological characterization of Sandoz proposed biosimilar adalimumab (GP2017): rationale for extrapolation across indications
ABSTRACT Background: Biosimilars are approved biologics that match reference medicine in quality, safety, and efficacy. The development of Sandoz proposed biosimilar adalimumab (SPBA; GP2017)Expand
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Factors Associated with Multibacillary Leprosy in a Priority Region for Disease Control in Northeastern Brazil: A Retrospective Observational Study
Background Leprosy is an infectious disease that can lead to physical disabilities and stigmatization. It remains an important public health problem, especially in Brazil. Objective To analyseExpand
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AB0412 Preclinical PK and Safety Assessment of the Proposed Adalimumab Biosimilar Gp2017, Compared to Humira®
Background TNFα inhibitors are highly effective drugs for the treatment of inflammatory disorders such as rheumatoid arthritis. Biosimilars are approved biologics with comparable quality, safety andExpand
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AB1403 Comprehensive target-directed approach for the development of a highly-comparable rituximab biosimilar
Background Biosimilars are successor drug products to a biologic medicine that is already authorized and whose patent is no longer valid. As with their originator products, biosimilars are expressedExpand
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