Guide to Biosimilars Litigation and Regulation in the U.S.
Author: Robert V. Cerwinski
Publisher:
Published: 2019
Total Pages: 686
ISBN-13: 9781539286721
DOWNLOAD EBOOK →Author: Robert V. Cerwinski
Publisher:
Published: 2019
Total Pages: 686
ISBN-13: 9781539286721
DOWNLOAD EBOOK →Author: Hiten J. Gutka
Publisher: Springer
Published: 2018-12-13
Total Pages: 709
ISBN-13: 3319996800
DOWNLOAD EBOOK →This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Author: World Intellectual Property Organization
Publisher: WIPO
Published: 2013
Total Pages: 259
ISBN-13: 9280523082
DOWNLOAD EBOOK →This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Author: Graham Dukes
Publisher: Edward Elgar Publishing
Published: 2014-06-27
Total Pages: 419
ISBN-13: 1783471107
DOWNLOAD EBOOK →The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr
Author: MATT. LAVY HERVEY (DR MATTHEW.)
Publisher:
Published: 2020
Total Pages:
ISBN-13: 9780414083028
DOWNLOAD EBOOK →Author: World Intellectual Property Organization
Publisher: WIPO
Published: 2023-04-19
Total Pages: 643
ISBN-13: 9280535153
DOWNLOAD EBOOK →Produced with the support of the University of California at Berkeley School of Law and the Berkeley Judicial Institute, this Guide highlights the progress achieved in patent case management in ten patent-heavy jurisdictions. The Guide offers an overview of the patent system in each jurisdiction, including the role of patent offices in evaluating and deciding on patent validity, and the judicial structures responsible for resolving patent disputes. Thereafter chapters are structured on the different stages of patent litigation in civil infringement cases. Readers can create their own custom guide by selecting any combination of jurisdictions and topics covered in the Guide. Please see the Custom guide link: https://www.wipo.int/about-patent-judicial-guide/en
Author: Robin Feldman
Publisher: Cambridge University Press
Published: 2017-06-09
Total Pages: 165
ISBN-13: 131673949X
DOWNLOAD EBOOK →While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2013-06-20
Total Pages: 377
ISBN-13: 0309269393
DOWNLOAD EBOOK →The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Author: BIRD & BIRD. LLP
Publisher:
Published: 2019
Total Pages:
ISBN-13: 9780414070547
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