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Biosimilars of Monoclonal Antibodies

Biosimilars of Monoclonal Antibodies
Author: Cheng Liu
Publisher: John Wiley & Sons
Total Pages: 720
Release: 2016-12-19
Genre: Medical
ISBN: 1118662318
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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

Safety of Biologics Therapy

Safety of Biologics Therapy
Author: Brian A. Baldo
Publisher: Springer
Total Pages: 623
Release: 2016-08-12
Genre: Medical
ISBN: 3319304720
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This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences.

Scientific and Regulatory Perspective on Monoclonal Antibody Biosimilars

Scientific and Regulatory Perspective on Monoclonal Antibody Biosimilars
Author: Po-Chih Wu
Publisher:
Total Pages:
Release: 2018
Genre: Medicine
ISBN:
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Similar biotherapeutic products (SBPs), also called biosimilars, exhibit similar biological and clinical properties to authorized reference products. Biosimilars, including small molecules like erythropoietin and complex macromolecules like monoclonal antibodies (mAbs), have been used extensively in disease treatment. Monoclonal antibody biosimilars have gradually become a dominant development in the global pharmaceutical industry since their patents or data protection have been expired or nearing expiration. Since the mAb biosimilars are complex biological macromolecules with various post-translation modifications, it is important to evaluate whether these tiny differences significantly affect the quality. From a regulatory perspective, the comparability study needs to be performed to demonstrate that the quality, safety, and efficacy are similar to the biological reference. Based on these comprehensive comparative results, the indicated extrapolation might be acceptable. Post-market surveillance is also required because of unexpected biological variation caused by slightly different manufacturing processes. This chapter presents the scientific and regulatory considerations for monoclonal antibody biosimilar products for manufactures and for the regulatory authorities to administrate wisely and comprehensively.

Monoclonal Antibodies

Monoclonal Antibodies
Author: Harleen Kaur
Publisher: Elsevier
Total Pages: 260
Release: 2021-08-03
Genre: Medical
ISBN: 0128223197
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Monoclonal antibodies (mAbs) are naturally occurring complex biomolecules. New engineering methods have turned mAbs into a leading therapeutic modality for addressing immunotherapeutic challenges and led to the rise of mAbs as the dominant class of protein therapeutics. mAbs have already demonstrated a great potential in developing safe and reliable treatments for complex diseases and creating more affordable healthcare alternatives. Developing mAbs into well-characterized antibody therapeutics that meet regulatory expectations, however, is extremely challenging. Obstacles to overcome include the determination and development of physiochemical characteristics such as aggregation, fragmentation, charge variants, identity, carbohydrate structure, and higher-order structure (HOS). This book dives deep into mAbs structure and the array of physiochemical testing and characterization methods that need to be developed and validated to establish a mAb as a therapeutic molecule. The main focus of this book is on physiochemical aspects, including the importance of establishing quality attributes such as glycosylation, primary sequence, purity, and HOS and elucidating the structure of new antibody formats by mass spectrometry. Each of the aforementioned quality attributes has been discussed in detail; this will help scientists in researching and developing biopharmaceuticals and biosimilars to find practical solutions to physicochemical testing and characterization. Describes the spectrum of analytical tests and characterization methods necessary for developing and releasing mAb batches Details antibody heterogeneity in terms of size, charge, and carbohydrate content Gives special focus to the structural analysis of mAbs, including mass spectrometry analysis Presents the basic structure of mAbs with clarity and rigor Addresses regulatory guidelines - including ICH Q6B - in relation to quality attributes Lays out characterization and development case studies including biosimilars and new antibody formats

Biosimilar Monoclonal Antibodies in Latin America

Biosimilar Monoclonal Antibodies in Latin America
Author: Gustavo Helguera
Publisher:
Total Pages: 0
Release: 2020
Genre: Medical
ISBN:
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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.

Biologics, Biosimilars, and Biobetters

Biologics, Biosimilars, and Biobetters
Author: Iqbal Ramzan
Publisher: John Wiley & Sons
Total Pages: 328
Release: 2021-02-03
Genre: Medical
ISBN: 1119564654
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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 in Hematology and Oncology

Fast Facts: Biosimilars in Hematology and Oncology
Author: Paul Cornes
Publisher: Karger Medical and Scientific Publishers
Total Pages: 130
Release: 2020-01-23
Genre: Medical
ISBN: 1912776219
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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

Hemodialysis

Hemodialysis
Author: Claudio Ronco
Publisher: Karger Medical and Scientific Publishers
Total Pages: 289
Release: 2008-01-01
Genre: Medical
ISBN: 3805585667
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Ronco and Cruz (both Dept. of Nephrology, San Bortolo Hospital, Vicenza, Italy) present a collection of 36 articles focusing on the physiological aspects of hemodialysis treatments as well as practical questions in the dialysis unit. Originally created as a supplement to the lectures presented at the 17th Annual International Course on Hemodialysis, a three-day event held in Vicenza, Italy, the text provides a valuable reference for the clinician interested in keeping up on developments in the field of hemodialysis. Thirty-six contributions by some 80 international academics, researchers, and practitioners are organized into ten sections covering dialysis technology, vascular access, epidemiology and practice, inflammation, fluid management, uremic toxicity, treatment efficacy, advanced techniques, calcium/phosphate homeostasis, and correction of anemia.

Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account

Rift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account
Author: Malik Osmane
Publisher: Anchor Academic Publishing (aap_verlag)
Total Pages: 282
Release: 2014-02-01
Genre: Medical
ISBN: 3954896877
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Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer’s point of view is to incorporate a design space.

Monoclonal Antibodies in Headache

Monoclonal Antibodies in Headache
Author: Antoinette Maassen van den Brink
Publisher: Springer Nature
Total Pages: 172
Release: 2021-04-28
Genre: Medical
ISBN: 3030690326
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Intended to promote a more appropriate and modern therapeutic approach to migraine management, this book is the first to deal with monoclonal antibodies in this context. Authored by the most respected migraine experts from around the globe and drawing on the lessons learned in both clinical trials and clinical practice, it reviews the current state of knowledge on this important therapeutic innovation, which has produced impressive data in randomized controlled trials, and the efficacy and safety of which have been confirmed in day-to-day real-world use. Given its scope, the book will appeal to a broad range of specialists, including pharmacologists, clinical pharmacologists, neurologists and internists, but also to residents and medical students.