BIOSIMILARS AND NEW INSULIN VERSIONS.

Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
Anne L PetersSteven V Edelman

Abstract

To provide clinicians with an overview of similar biologic products including biosimilars and new insulin versions available in the U.S. and of key issues associated with such products, including differences in manufacturing and regulatory approaches and their impact on clinical use. We reviewed the relevant clinical and regulatory literature. Patent protections for many biologics including several insulin preparations have or will expire shortly. This opens the door for new insulin versions to enter the U.S. and global marketplace. The development, manufacturing, and approval process for similar biologic products is more complex than for generic versions of small molecules. Most similar biologic products in the U.S. will be submitted for approval under section 351(k), a newly created biosimilar regulatory pathway. However, some biologics, including new insulin versions, will be submitted via the existing 505(b)(2) regulatory pathway. These regulatory pathways have implications for how such products may be labeled, how they may be dispensed, and how patients may perceive them. The immunogenicity of biologics can affect safety and efficacy and can be altered through subtle changes in manufacturing. With the arrival of new insuli...Continue Reading

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Citations

Mar 1, 2016·Postgraduate Medicine·Adrienne BarnoskyAlaleh Mazhari
Nov 9, 2016·Endocrinology and Metabolism Clinics of North America·Alissa R SegalRichard S Beaser
Jan 25, 2017·Diabetes Technology & Therapeutics·Luigi F Meneghini, Jacqueline Nicole McNulty
Oct 9, 2018·Expert Opinion on Biological Therapy·Jingbo HuYufen Zhao
Mar 17, 2018·Biochemistry. Biokhimii︠a︡·O M SelivanovaO V Galzitskaya
Nov 26, 2019·American Journal of Therapeutics·Francisco Javier Ampudia-Blasco

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