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Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology
Biologics are vital to the management of patients with rheumatic and musculoskeletal diseases such as rheumatoid arthritis and other inflammatory and autoimmune conditions. Nevertheless, access toExpand
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The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects
Biologic therapies have revolutionized treatment of a number of diseases. Patents and exclusivity for a number of biologics are expiring. This has created the opportunity for the development andExpand
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Bevacizumab in Colorectal Cancer: Current Role in Treatment and the Potential of Biosimilars
Colorectal cancer (CRC) is a leading cause of tumor-related morbidity and mortality worldwide, with mortality most often attributable to metastatic disease. Bevacizumab, a humanized monoclonalExpand
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Assessing the Immunogenicity of Biopharmaceuticals
Biopharmaceuticals have the potential to raise an immunogenic response in treated individuals, which may impact the efficacy and safety profile of these drugs. As a result, it is essential toExpand
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Key considerations in the preclinical development of biosimilars.
Biosimilar development requires several steps: selection of an appropriate reference biologic, understanding the key molecular attributes of that reference biologic and development of a manufacturingExpand
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Biosimilar Drugs for Psoriasis: Principles, Present, and Near Future
Psoriasis is a chronic, inflammatory, lifelong disease with a high prevalence (afflicting approximately 1–5% of the population worldwide) and is associated with significant morbidity. TheExpand
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Patient attitudes and understanding about biosimilars: an international cross-sectional survey
Objective To understand the levels of awareness, usage, and knowledge of biosimilars among patients, caregivers, and the general population in the US and the European Union; perceptions ofExpand
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Biosimilars in oncology: from development to clinical practice.
Biologics play an integral role in the treatment of cancer not only for their therapeutic effects and ability to improve outcomes, but also as supportive care agents. Biologics are more complex toExpand
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Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence
BackgroundDespite regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and theExpand
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Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence
BackgroundClinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications.ObjectivesThe objective of this studyExpand
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