Biosimilar and Interchangeable Biologics: From Cell Line to Commercial Launch, Two Volume Set

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Sarfaraz K. Niazi (Therapeutic Proteins International, LLC, Chicago, Illinois, USA)

Biosimilar and Interchangeable Biologics

From Cell Line to Commercial Launch, Two Volume Set

Sarfaraz K. Niazi (Therapeutic Proteins International, LLC, Chicago, Illinois, USA)

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English

Apple Academic Press Inc.
23 December 2015

Biotechnology; Pharmaceutical technology

What's the Deal with Biosimilars?

Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development.

Biosimilars and Interchangeable Biologics: From Cell Line to Commercial Launch covers the strategic and tactical elements of biosimilars in two volumes.

The first volume, Biosimilars and Interchangeable Biologics: Strategic Elements, explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets.

This volume also examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

The second volume, Biosimilars and Interchangeable Biologics: Tactical Elements, explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products.

This volume also provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.

Thus, Biosimilars and Interchangeable Biologics: From Cell Line to Commercial Launch, Two-Volume Set supplies practitioners, researchers, and scientists in the biopharmaceutical industry with a valuable resource for practical information at all stages of the biosimilar product process.

By: Sarfaraz K. Niazi (Therapeutic Proteins International LLC Chicago Illinois USA)
Imprint: Apple Academic Press Inc.
Country of Publication: Canada
Dimensions: Height: 280mm, Width: 210mm,
Weight: 4.331kg
ISBN: 9781482298918
ISBN 10: 1482298910
Pages: 1174
Publication Date: 23 December 2015
Audience: General/trade , College/higher education , Professional and scholarly , ELT Advanced , Primary
Format: Mixed media product
Publisher's Status: Active

Biosimilars and Interchangeable Biologics: Strategic Elements. Introduction to Biosimilar and Interchangeable Products. Intellectual Property Issues for Biosimilars. European Regulatory Guidance. EMA-Approved Biosimilars. FDA Regulatory Guidance. ROW Regulatory Guidance. US Commercialization. Global Commercialization. Quality and Lifecycle Management. Biosimilars and Interchangeable Biologics: Tactical Elements. Structural and Functional Elements. Immunogenicity Considerations. Product Development Strategies. Stability and Formulation Considerations. Biosimilarity Tetrahedron. Recombinant Expression Systems. Upstream Systems Optimization. Downstream Systems Optimization. Single-Use Manufacturing Systems (SUMS). Commercial Manufacturing Overview. Outsourcing Considerations. Appendix: Glossary of Terms.

Sarfaraz K. Niazi, PhD, is the founding executive chairman of Therapeutic Proteins International LLC, a world-class pure-play developer and manufacturer of biosimilar and interchangeable recombinant biologics, headquartered in Chicago. Dr. Niazi began his career teaching pharmacy at the University of Illinois (1972-1988), where he became a tenured professor. He then entered the pharmaceutical industry at Abbott International, becoming a Volwiler Fellow. He left Abbott in 1995 with a passion for making high-cost biological drugs affordable. Dr. Niazi set up several ex-U.S. biosimilar companies and, in 2003, established Therapeutic Proteins International, the only U.S. integrated company of its kind to date.