Fast Facts Biosimilars In Hematology And Oncology

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 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?

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 have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.

Upper Tract Urothelial Carcinoma represents the first book of its kind to be dedicated solely to UTUC. It's aim is to improve understanding and eventually care of a disease that is greatly understudied and underappreciated, yet commonly dealt with by many medical and urologic oncologists. The volume features new data regarding genetic susceptibility, gene expression studies and causative factors; contemporary concepts and controversies regarding diagnosis and staging of UTUC; prediction tools and their value in treatment decisions within each disease stage and patient selection and treatment options such as endoscopic management, distal ureterectomy, radical nephroureterectomy and chemotherapy. Up-to-date information regarding boundaries of surgical resection, indication and extent of lymphadenectomy is covered as well as the role of perioperative/neoadjuvant chemotherapy in patients with high-risk UTUC. Upper Tract Urothelial Carcinoma will be of great value to all Urologists, Medical Oncologists and fellows in Urologic Oncology as well as upper level residents in training in Urology and Medical Oncology.

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.

This book provides the current state of knowledge of basic mechanisms of adverse drug reactions (ADRs). The main focus is on idiosyncratic drug reactions because they are the most difficult to deal with. It starts with a general description of the major targets for ADRs followed by a description of what are presently believed to be mediators and biochemical pathways involved in idiosyncratic drug reactions. There is also a description of several examples of ADRs that serve to illustrate specific aspects of ADR mechanisms. Eventually the book shows that ultimately better methods are needed to predict which drug candidates are likely to cause ADRs and which patients are at increased risk. But at present research seems to be far from this goal.

The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.