Biologics And Biosimilars
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Biologics And Biosimilars
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Author : Xiaodong Feng
language : en
Publisher: CRC Press
Release Date : 2022-06-13
Biologics And Biosimilars written by Xiaodong Feng and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-06-13 with Medical categories.
Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.
Handbook Of Biologics Biosimilars In Dermatology
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Author : Manas Chatterjee
language : en
Publisher: JP Medical Ltd
Release Date : 2018-08-16
Handbook Of Biologics Biosimilars In Dermatology written by Manas Chatterjee and has been published by JP Medical Ltd this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-16 with Medical categories.
A drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process. Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. A biosimilar is a biologic that is similar to another biologic drug already that has already been approved. This book is a complete guide to the use of biologics and biosimilars in the treatment of dermatologic disorders. Beginning with an overview of the history and classification of biologics and the concept of biosimilars, the following chapters explain their therapeutic use for different skin conditions. The final sections cover related topics such as cost effectiveness and quality of life with biologic therapy, and the book concludes with discussion on future developments and the use of small molecule treatment. Key points Complete guide to use of biologics and biosimilars in treatment of dermatologic disorders Covers many different skin diseases and conditions Discusses related topics such as cost effectiveness and quality of life Covers future development of small molecule therapy
Fast Facts Biosimilars In Hematology And Oncology
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Author : P. Cornes
language : en
Publisher: Karger Medical and Scientific Publishers
Release Date : 2020-01-24
Fast Facts Biosimilars In Hematology And Oncology written by P. Cornes and has been published by Karger Medical and Scientific Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-01-24 with Medical categories.
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
Biologics And Biosimilars
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Author : Congressional Research Service
language : en
Publisher: Createspace Independent Publishing Platform
Release Date : 2017-11-13
Biologics And Biosimilars written by Congressional Research Service and has been published by Createspace Independent Publishing Platform this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-13 with Biologicals categories.
A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and/or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Biologics may also be cells or tissues used in transplantation. A biosimilar, sometimes referred to as a follow-on biologic, is a therapeutic drug that is similar but not structurally identical to the brand-name biologic made by a pharmaceutical or biotechnology company. In contrast, a generic chemical drug is an exact copy of a brand-name chemical drug. Because biologics are more complex than chemical drugs, both in composition and method of manufacture, biosimilars will not be exact replicas of the brand-name product, but may instead be shown to be highly similar. The Food and Drug Administration (FDA) regulates both biologics and chemical drugs. Biologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. Also, they are usually administered to patients via injection or infused directly into the bloodstream. For these reasons, biologics often are referred to as specialty drugs, which can be very costly. In April 2006, the European Medicines Agency (EMA) authorized for marketing in Europe the first biosimilar product, Omnitrope, a human growth hormone. Today a total of 35 biosimilars are EMA-authorized for the European market. The introduction of biosimilars in Europe has reduced prices for biologics by up to 33%. For one drug in Portugal, the price reduction was 61%. In contrast, the pathway to marketing biosimilars in the United States has had several barriers. FDA approved Omnitrope in June 2006, following an April 2006 court ruling requiring the FDA to move forward with consideration of the application. At the time the FDA indicated that this action "does not establish a pathway" for approval of other follow-on biologic drugs and stated that Congress must change the law before the agency can approve copies of nearly all other such products. In March 2010 Congress established a new regulatory authority for FDA by creating an abbreviated licensure pathway for biological products demonstrated to be "highly similar" (biosimilar) to or "interchangeable" with an FDA-licensed biological product. The new authority was accomplished via the Biologics Price Competition and Innovation Act (BPCIA) of 2009, enacted as Title VII of the Affordable Care Act. Congress authorized FDA to collect associated fees via the Biosimilar User Fee Act of 2012 (BsUFA). The five-year biosimilars user fee authority was set to expire on September 30, 2017. Congress reauthorized the biosimilar user fee program via the Food and Drug Administration Reauthorization Act of 2017. As more biosimilars enter the U.S. market, analysts expect to see U.S. price reductions similar to those that have occurred in Europe. However, of the seven biosimilars approved by FDA, sales of five biosimilars have been delayed, or (allegedly) adversely impacted, by actions of the brand-name manufacturers, including patent infringement lawsuits and suits over alleged anticompetitive contracts with insurers in order to prevent coverage of biosimilars that are less expensive substituted for best-selling biologics. The high costs of pharmaceuticals in general-and biologics in particular-has led to an increased interest in understanding the federal government's role in the development of costly new therapeutics. In the case of six of the seven biosimilars approved by FDA, the associated brand-name drug was originally discovered by scientists at public-sector research institutions.
Biologics And Biosimilars
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Author : United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy
language : en
Publisher:
Release Date : 2010
Biologics And Biosimilars written by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Biologicals categories.
Biosimilars
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Author : Jean-Louis Prugnaud
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-11-27
Biosimilars written by Jean-Louis Prugnaud and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-11-27 with Medical categories.
Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.
Biologics Biosimilars And Biobetters
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Author : Iqbal Ramzan
language : en
Publisher: John Wiley & Sons
Release Date : 2021-01-05
Biologics Biosimilars And Biobetters written by Iqbal Ramzan and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-05 with Medical categories.
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
Fast Facts Biosimilars
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Author : Paul Cornes
language : en
Publisher: Karger Medical and Scientific Publishers
Release Date : 2018-04-09
Fast Facts Biosimilars written by Paul Cornes and has been published by Karger Medical and Scientific Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-04-09 with Medical categories.
Biosimilars have been in clinical use for more than 10 years, and evidence from more than 700 million patient-days’ exposure shows that approved biosimilars can be used as safely and effectively as their originator biologics. And yet concerns about these drugs persist, particularly in therapy areas where they are recent additions to the formulary. It is vital to address these concerns so that clinicians can prescribe biosimilars with confidence, realizing substantial cost savings and improving patient access to effective treatments. 'Fast Facts: Biosimilars' provides a comprehensive yet concise explanation of biosimilars: what they are, how they are regulated, and how they are used in clinical practice. It is ideal for healthcare professionals and decision makers who want to understand biosimilars and the key concerns and controversies around these valuable products. Contents: 1 - An introduction to biologics and biosimilars 2 - Why do we need biosimilars? 3 - How is the quality of biosimilars assured? 4 - How is the efficacy and safety of biosimilars ensured? 5 - What has been the experience with biosimilars to date? 6 - The future of biosimilar medicines 7 - How do I use biosimilar medicines?
Biosimilar Drug Product Development
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Author : Laszlo Endrenyi
language : en
Publisher: CRC Press
Release Date : 2017-02-24
Biosimilar Drug Product Development written by Laszlo Endrenyi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-24 with Medical categories.
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Biosimilars And Interchangeable Biologics
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Author : Sarfaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2018-10-30
Biosimilars And Interchangeable Biologics written by Sarfaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-30 with Medical categories.
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.