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.
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