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

Biosimilar drugs are one of the hottest subjects in the field of new drug development, with scores of companies offering seminars and training programs for prospective manufacturers and stakeholders. This two-volume set provides a modern and comprehensive overview of the entire biosimilar manufacturing and distribution process, covering concepts introduced by the FDA, as well as litigation strategies, analytical methods, pharmokinetic studies, and the current and future status of biosimilar product approvals.

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.