Fast Facts: Biosimilars in Hematology and Oncology
Fast Facts: Biosimilars in Hematology and Oncology

Author: P. Cornes

Publisher: Karger Medical and Scientific Publishers

Published: 2020-01-24

Total Pages: 130

ISBN-13: 1912776227

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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

Fast Facts: Biosimilars in Hematology and Oncology
Fast Facts: Biosimilars in Hematology and Oncology

Author: Paul Cornes

Publisher: Karger Medical and Scientific Publishers

Published: 2020-01-23

Total Pages: 130

ISBN-13: 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

Fast Facts: Biosimilars
Fast Facts: Biosimilars

Author: Guy Regnard

Publisher: Karger Medical and Scientific Publishers

Published: 2024-08-28

Total Pages: 161

ISBN-13: 3318073830

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Biologic medicines have revolutionized the treatment of many serious disorders. Biosimilars offer similar safety and efficacy at a fraction of the cost, though while they have led to significant savings, uptake varies globally due to concerns and regulatory inconsistencies, especially in middle-income countries where the need for affordable drugs is greatest. 'Fast Facts: Biosimilars: A Global Perspective' has taken a specifically global perspective, with expert contributors invited to represent a range of medical specialties, including endocrinology, hematology, oncology and immunology, and regions of the world. It addresses the following concerns, drawing on the most up-to-date information in this fast-moving area of medicine: Is the quality of the biosimilar medicine equivalent to that of the original drug? Is the biosimilar medicine safe? Which indications can the biosimilar medicine be used for? What are the realistic economic benefits? How do I switch a patient from a biologic to an equivalent biosimilar medicine? How do I select biologics in a region with regulatory uncertainty over biosimilars? How do I explain biosimilars to patients?

Fast Facts: Biosimilars
Fast Facts: Biosimilars

Author: Paul Cornes

Publisher: Karger Medical and Scientific Publishers

Published: 2018-04-09

Total Pages: 72

ISBN-13: 1910797677

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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?

Biologics, Biosimilars, and Biobetters
Biologics, Biosimilars, and Biobetters

Author: Iqbal Ramzan

Publisher: John Wiley & Sons

Published: 2021-02-03

Total Pages: 328

ISBN-13: 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

Pharmaceutical Medicine and Translational Clinical Research
Pharmaceutical Medicine and Translational Clinical Research

Author: Divya Vohora

Publisher: Academic Press

Published: 2017-11-14

Total Pages: 527

ISBN-13: 0128020989

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Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. - Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and - Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Biologic and Systemic Agents in Dermatology
Biologic and Systemic Agents in Dermatology

Author: Paul S. Yamauchi

Publisher: Springer

Published: 2018-01-02

Total Pages: 567

ISBN-13: 3319668846

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Written by leading experts in the field and designed for dermatologists and residents, this book includes evidence-based medicine that underscores the clinical data, as well as practical tips on how to use both biologic and systemic agents in the field of dermatology. In the past decade, there have been several groundbreaking advances in medical dermatology. Novel biologic and systemic agents have been developed to treat inflammatory disorders, including psoriasis and atopic dermatitis, as well as skin malignancies such as melanoma. Biologic and Systemic Agents in Dermatology encompasses these developments by describing the mechanism of action of these various agents and the clinical efficacy and safety to treating these respective disorders. The utilization of biologic and systemic agents in other dermatologic conditions, pharmacoeconomics, pharmacovigilance, and clinical trials outcomes are discussed as well as topics including tumor necrosis, conventional systemic agents for psoriatic disease, and oral agents for atopic dermatitis.

The Business of Healthcare Innovation
The Business of Healthcare Innovation

Author: Lawton Robert Burns

Publisher: Cambridge University Press

Published: 2005-08-25

Total Pages: 408

ISBN-13: 9781139445887

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The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants.

Biosimilars and Interchangeable Biologics
Biosimilars and Interchangeable Biologics

Author: Sarfaraz K. Niazi

Publisher: CRC Press

Published: 2018-10-30

Total Pages: 646

ISBN-13: 149874348X

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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.

Biosimilarity
Biosimilarity

Author: Sarfaraz K. Niazi

Publisher: CRC Press

Published: 2018-10-03

Total Pages: 455

ISBN-13: 1315351374

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Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilars Presents the first approach to challenge FDA in reducing or eliminating any testing in patients. Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars