Biosimilars and Interchangeable Biologics

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. These biological drugs are produced by recombinant DNA technology, allowing for large-scale production and an overall reduction in time and costs of development.

Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars, targeting challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets where regulatory agencies are still developing guidelines. The text addresses the complexity of biological drugs, discussing specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products.

Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume 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 assists in developing and manufacturing a biosimilar product while reducing overall production costs. It also meets the requirements of biosimilarity based on analytical and functional assessments, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate), while remaining competitive in the market.