Biologics, Biosimilars, and Biobetters

Biologics, Biosimilars, and Biobetters
Author :
Publisher : John Wiley & Sons
Total Pages : 328
Release :
ISBN-10 : 9781119564652
ISBN-13 : 1119564654
Rating : 4/5 (52 Downloads)

Synopsis Biologics, Biosimilars, and Biobetters by : Iqbal Ramzan

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

Biosimilars and Interchangeable Biologics

Biosimilars and Interchangeable Biologics
Author :
Publisher : CRC Press
Total Pages : 599
Release :
ISBN-10 : 9781498743488
ISBN-13 : 149874348X
Rating : 4/5 (88 Downloads)

Synopsis Biosimilars and Interchangeable Biologics by : Sarfaraz K. Niazi

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. Part of a two-volume set that covers varying aspects of biosimilars, 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. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume 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 also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Biosimilars

Biosimilars
Author :
Publisher : CRC Press
Total Pages : 447
Release :
ISBN-10 : 9781466579699
ISBN-13 : 1466579692
Rating : 4/5 (99 Downloads)

Synopsis Biosimilars by : Shein-Chung Chow

As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator’s biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products. Written by a top biostatistics researcher, Biosimilars: Design and Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products. Connecting the pharmaceutical/biotechnology industry, government regulatory agencies, and academia, this state-of-the-art book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.

Fast Facts: Biosimilars in Hematology and Oncology

Fast Facts: Biosimilars in Hematology and Oncology
Author :
Publisher : Karger Medical and Scientific Publishers
Total Pages : 130
Release :
ISBN-10 : 9781912776214
ISBN-13 : 1912776219
Rating : 4/5 (14 Downloads)

Synopsis Fast Facts: Biosimilars in Hematology and Oncology by : Paul Cornes

Biologics have revolutionized – and are revolutionizing – the treatment of many serious disorders. The evidence acquired from more than 10 years of clinical experience, with more than 50 biosimilar drugs and more than 700 million patient-days' exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. Yet concerns persist about biosimilars – particularly in curative cancer treatment, where they are relatively recent therapeutic options. 'Fast Facts: Biosimilars in Hematology and Oncology' provides a concise overview of emerging global practice in this fast-moving area together with practical information on adding biosimilars to a formulary and switching patients. Contents: • Biologics and the need for biosimilars • Why do we need biosimilars? • How is the quality of biosimilar medicines assured? • Legal issues • Switching, interchangeability and extrapolation • Safety and pharmacovigilant • Global issues • Formulary considerations: pharmacy issues • Formulary considerations: supportive care biosimilars • Formulary considerations: therapeutic anti-cancer biosimilars • Communication and awareness

Biosimilars

Biosimilars
Author :
Publisher : Springer
Total Pages : 713
Release :
ISBN-10 : 9783319996806
ISBN-13 : 3319996800
Rating : 4/5 (06 Downloads)

Synopsis Biosimilars by : Hiten J. Gutka

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.

Pharmacoepidemiology

Pharmacoepidemiology
Author :
Publisher : John Wiley & Sons
Total Pages : 1220
Release :
ISBN-10 : 9781119413417
ISBN-13 : 1119413419
Rating : 4/5 (17 Downloads)

Synopsis Pharmacoepidemiology by : Brian L. Strom

This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.

Biosimilar and Interchangeable Biologics

Biosimilar and Interchangeable Biologics
Author :
Publisher : CRC Press
Total Pages : 0
Release :
ISBN-10 : 1482298910
ISBN-13 : 9781482298918
Rating : 4/5 (10 Downloads)

Synopsis Biosimilar and Interchangeable Biologics by : Sarfaraz K. Niazi

The field of biosimilar drugs is one of the hottest subjects in the filed of new drug development, with scores of companies offering seminar and training programs for prospective manufacturers and stakeholders. This book is a modern comprehensive overview of the entire biosimilar manufacturing and distribution process, covering concepts introduced by the FDA, litigation strategies, analytical methods, pharmokinetic studies, and the future and current status of biosimilar product approvals.

Protein Therapeutics, 2 Volume Set

Protein Therapeutics, 2 Volume Set
Author :
Publisher : John Wiley & Sons
Total Pages : 762
Release :
ISBN-10 : 9783527340866
ISBN-13 : 3527340866
Rating : 4/5 (66 Downloads)

Synopsis Protein Therapeutics, 2 Volume Set by : Tristan Vaughan

Branchenführende Big-Pharma-Unternehmen und erstklassige Forscher präsentieren grundlegende Konzepte und Herausforderungen bei proteinbasierten Pharmazeutika. Beinhaltet auch eine Einführung in die aus Sicht der Arzneimittelentwicklung fünf wesentlichen Anwendungsbereiche.

Safe and Effective Medicines for Children

Safe and Effective Medicines for Children
Author :
Publisher : National Academies Press
Total Pages : 432
Release :
ISBN-10 : 9780309225496
ISBN-13 : 0309225493
Rating : 4/5 (96 Downloads)

Synopsis Safe and Effective Medicines for Children by : Institute of Medicine

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.