Copied Biosimilars
Biosimilars
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.
Price Comparison
| Seller | Contact Seller | List Price | On Sale | Shipping | Best Promo | Final Price | Volume Discount | Financing | Availability | Seller's Page |
|---|---|---|---|---|---|---|---|---|---|---|
|
BEST PRICE 1 Product Purchase
|
|
$99.00 | $99.00 |
|
$99.00 | See Site | In stock | Visit Store |
Reviews
Questions & Answers
Alkaline Phosphatase
$219.99
Materials EngineeringFrom Ideas to Practice: An EPD Symposium in Honor of Jiann-Yang Hwang
$169.00
Zur Legitimitt der Familienstiftung
$89.99
Evolutionary Image Analysis and Signal Processing
$169.99
Adaptive and Natural Computing Algorithms
$54.99
Knowledge and Liberation in Classical Indian Thou
$84.99
Supercomputing
$119.99
National Geographic Kids: Chapters: Tiger in Trouble!
$5.21
Computers in Analytical Chemistry
$54.99
Topics in Mathematical Fluid Mechanics
$39.99
The Impact of 9/11 on Religion and Philosophy
$39.99
Rewriting Techniques and Applications
$44.99
Lie Groups Beyond an Introduction
$74.99
Grid and Distributed Computing
$84.99
Kreative Methoden im Business Coaching
$17.99
MedRevolution
$24.99
Die Lebensfhrung der Gesellschaft
$49.99
Automatic Programming Applied to VLSI CAD Software: A Case Study
$169.99
Anesthesia Student Survival Guide
$44.99
Sustainable Crop Protection under Protected Cultivation
$249.99
Spinal Disorders in Growth and Aging
$39.99
Anglo-American Stage and Screen Drama
$119.99
Testability Concepts for Digital ICs
$129.00
Women, Science and Fiction
$84.99
Formal Techniques for Distributed Objects, Components, and Systems
$69.99
Handbook of Multivalued Analysis
$129.00
Higher! Higher!
$5.21
Hong Kong and the Asylum-Seekers from Vietnam
$109.99
Sozialistische Eliten
$59.99
Metastasis Research Protocols
$109.99
Taurine 11
$449.99
Medical Entomology
$599.99
Handbuch Weimarer Republik
$79.99
Computational Intelligence in der Materialwirtschaft
$59.99
Herbst-/Winterdepression und Lichttherapie
$54.99
Phytochemicals, Signal Transduction, and Neurological Disorders
$129.00
When Was Latin America Modern?
$109.99
Visual Communication Theory and Research
$109.99
Repetitorium der Hygiene und Bakteriologie in Frage und Antwort
$59.99
Umweltstrafrecht
$39.99
