In the last decade, the expiration of patents protecting therapeutic monoclonal antibodies opened an opportunity for the development and approval of biosimilar versions of these drugs. The complexity of these biologic molecules required the imposition of strict regulations to establish robust comparability with the antibody of reference in physicochemical, analytical, biological and, when deemed necessary, clinical data. Accordingly, this period coincides with the updating of the requirements and guidelines for the manufacture and approval of biologics in Latin American countries by their respective regulatory agencies. Although the term ,Äúbiosimilar,Äù does not appear in the official regulatory provisions in most of the countries, it is of general use in Latin America, and several biosimilars of therapeutic monoclonal antibodies were approved based on comparative quality, nonclinical and clinical data that demonstrate similarity to a licensed biological reference registered before in a Regulatory Health Authority of reference. Here, we provide an overview of how the complexities of therapeutic monoclonal antibodies shaped the regulatory landscape of similar biologics, the current status of biosimilar monoclonal antibodies in Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, M√©xico, Paraguay, Per√∫ and Uruguay and their potential to reduce the cost of antibody therapies in this region.

Introduced in the 1980s, biologic medications have since become important tools in modern medicine. However, biologics are expensive, greatly affecting the healthcare budgets of both underdeveloped and developed countries. Fortunately, biosimilars, which are highly similar, reverse-engineered versions of existing biological medicines and their active ingredients, are now available as more affordable options for patients treated with biologics. This book discusses biosimilars with chapters on clinical trials, regulation, pharmacovigilance, and the interchangeability of biosimilars with biologics. It also addresses future trends in the biosimilars market.

A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists

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

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

Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.

Granulocyte colony-stimulating factor (G-CSF or GCSF) is a secreted glycoprotein that stimulates the proliferation and differentiation of granulocyte precursor cells, and induces mobilization of peripheral blood progenitor cells from the bone marrow. Development of recombinant human G-CSF has had a profound impact on the treatment of many diseases, including severe chronic neutropenia and cancer, and has enabled peripheral stem cell transplantation to supplant bone marrow transplantation in the autologous setting. This Milestones in Drug Therapy volume describes the experience of the last 20 years of treatment with recombinant human G-CSF, including the basic science, the use of recombinant human G-CSF in both the oncology and nononcology settings, and the safety and economics of its use. Many of the authors were the original investigators of recombinant human G-CSF and other authors are key researchers who provide their outlook for the next 20 years for use of and research with recombinant human G-CSF.

Mass spectrometry is fast becoming an indispensable field for medical professionals. The mass spectrometric analysis of metabolites and proteins promises to revolutionize medical research and clinical diagnostics. As this technology rapidly enters the medical field, practicing professionals and students need to prepare to take full advantage of its capabilities. Medical Applications of Mass Spectrometry addresses the key issues in the medical applications of mass spectrometry at the level appropriate for the intended readership. It will go a long way to help the utilization of mass spectrometry in medicine.The book comprises five parts. A general overview is followed by a description of the basic sampling and separation methods in analytical chemistry. In the second part a solid foundation in mass spectrometry and modern techniques of data analysis is presented. The third part explains how mass spectrometry is used in exploring various classes of biomolecules, including proteins and lipids. In the fourth section mass spectrometry is introduced as a diagnostic tool in clinical treatment, infectious pathogen research, neonatal diagnostics, cancer, brain and allergy research, as well as in various fields of medicine: cardiology, pulmonology, neurology, psychiatric diseases, hemato-oncology, urologic diseases, gastrointestinal diseases, gynecology and pediatrics. The fifth part covers emerging applications in biomarker discovery and in mass spectrometric imaging.* Provides a broad look at how the medical field is benefiting from advances in mass spectrometry.* Guides the reader from basic principles and methods to cutting edge applications.* There is NO comparable book on the market to fill this fast growing field.

Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. The chapters range from an overview of the immune system and factors that may trigger the immune system, via detection of antibodies and clinical implications, to various case examples and the regulatory view on immunogenicity.