Titlebook: Biosimilars; Regulatory, Clinical Hiten J. Gutka,Harry Yang,Shefali Kakar Book 2018 American Association of Pharmaceutical Scientists 2018

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The Changing US Reimbursement Landscape and Biosimilarse passage of the Affordable Care Act (ACA) created an FDA approval pathway for biosimilars, but that is the tip of the iceberg as it pertains to how a biosimilar will actually get to the patient. As a general rule, legislation contains very little detail and requires much regulatory guidance by vari

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Design and Implementation of Successful Regulatory Strategies in Biosimilar Developmenten shown to provide “dramatically reduced disability for patients with inflammatory diseases, such as rheumatoid arthritis, extended the lives of patients with many cancers and also provide lifesaving replacement proteins for patients with rare diseases” (US Food and Drug Administration, .; Krishnan

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EU Perspective on Biosimilarsation is granted by the Commission of the European Union (EU). Thus, each biosimilar has one regulatory assessment as well as the same product information and conditions of use in the EU. The current regulatory framework is a result of 20 years evolution of legislation and regulatory guidelines. The

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QbD in Biopharmaceutical Manufacturing and Biosimilar Developments had been proven, clinical efficacy and safety profiles established, with large markets and sales margins, making them attractive targets for many biopharmaceutical companies, both large and small. However, inherent properties of the molecules result in higher levels of risk in the eyes of regulato

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Drug Product Considerations for Biosimilarsn of the drug product for a biosimilar is of utmost importance, as it directly relates to patient efficacy, safety and product quality, even as it defines the similarity of the product to the reference innovator product. There are various components of a drug product: the formulation, the container