Articles liés à Biosimilars Development Strategies

Biosimilars Development Strategies - Couverture souple

Niazi, Sarfaraz K.

 
9781032519586: Biosimilars Development Strategies
Couverture souple
ISBN 10 : 1032519584 ISBN 13 : 9781032519586
Editeur : CRC Press, 2025

Synopsis

After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep analysis of the scientific principles, and continuous challenges to the regulatory authorities have made it possible to plan the development on a fast track. This book teaches how to cut the current time and cost by more than 70%, based on the author's hands-on experience.

Features:

  • Describes the emergence of biosimilars since the first publication of the recombinant engineering patent, as well as a listing of all approved recombinant products, their patent expiry and their adoption across the globe.
  • Provides a better understanding of the safety and efficacy of approved biosimilars.
  • Global approval requires accommodating guidelines and detailed planning to avoid redundancy as well as high costs. The basic expectations of the agencies are presented here.
  • Presents a detailed analysis of all EU and FDA-approved products with a comparative analysis.
  • Renowned author and entrepreneur in the field of drug discovery and production.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

À propos de l'auteur

Sarfaraz K Niazi, Ph.D., is an Adjunct Professor at the University of Illinois. He has authored 60+ major books, 100+ research papers, and 100+ patents, mainly in bioprocessing. He has hands-on experience establishing biopharmaceutical projects, from concept to market, including setting up the first biosimilar company in the US and leading to several FDA approvals. He serves as an advisor to several regulatory agencies, including the FDA.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
CRC Press
Date d'édition
2025
Langue
anglais
ISBN 10 
1032519584
ISBN 13 
9781032519586
Reliure
Broché
Nombre de pages
198
Coordonnées du fabricant
CRC Press
https://www.routledge-ny.com

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