Biosimilars of Monoclonal Antibodies - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biosimilars of Monoclonal Antibodies write by Cheng Liu. This book was released on 2016-12-09. Biosimilars of Monoclonal Antibodies available in PDF, EPUB and Kindle. Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs • Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible • Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information • Examines new technologies and strategies for improving biosimilar mAbs
Scientific and Regulatory Perspective on Monoclonal Antibody Biosimilars
Scientific and Regulatory Perspective on Monoclonal Antibody Biosimilars - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Scientific and Regulatory Perspective on Monoclonal Antibody Biosimilars write by Po-Chih Wu. This book was released on 2018. Scientific and Regulatory Perspective on Monoclonal Antibody Biosimilars available in PDF, EPUB and Kindle. Similar biotherapeutic products (SBPs), also called biosimilars, exhibit similar biological and clinical properties to authorized reference products. Biosimilars, including small molecules like erythropoietin and complex macromolecules like monoclonal antibodies (mAbs), have been used extensively in disease treatment. Monoclonal antibody biosimilars have gradually become a dominant development in the global pharmaceutical industry since their patents or data protection have been expired or nearing expiration. Since the mAb biosimilars are complex biological macromolecules with various post-translation modifications, it is important to evaluate whether these tiny differences significantly affect the quality. From a regulatory perspective, the comparability study needs to be performed to demonstrate that the quality, safety, and efficacy are similar to the biological reference. Based on these comprehensive comparative results, the indicated extrapolation might be acceptable. Post-market surveillance is also required because of unexpected biological variation caused by slightly different manufacturing processes. This chapter presents the scientific and regulatory considerations for monoclonal antibody biosimilar products for manufactures and for the regulatory authorities to administrate wisely and comprehensively.
Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account
Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account write by Malik Osmane. This book was released on 2014-02-01. Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account available in PDF, EPUB and Kindle. Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer’s point of view is to incorporate a design space.
Biosimilars
Biosimilars - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biosimilars write by Hiten J. Gutka. This book was released on 2018-12-13. Biosimilars available in PDF, EPUB and Kindle. This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Current Trends in Monoclonal Antibody Development and Manufacturing
Current Trends in Monoclonal Antibody Development and Manufacturing - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Current Trends in Monoclonal Antibody Development and Manufacturing write by Steven J. Shire. This book was released on 2008-11-01. Current Trends in Monoclonal Antibody Development and Manufacturing available in PDF, EPUB and Kindle. Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.
