Biosimilars Development Strategies

Fast to Market Approaches

Sarfaraz K. Niazi (Therapeutic Proteins International, LLC, USA)

$231

Hardback

Forthcoming
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English

CRC Press
31 July 2024

Chemistry; Life sciences: general issues; Engineering: general; Pharmaceutical technology; Environmental science, engineering & technology

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.

By: Sarfaraz K. Niazi (Therapeutic Proteins International LLC USA)
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 234mm, Width: 156mm,
Weight: 530g
ISBN: 9781032517018
ISBN 10: 1032517018
Pages: 188
Publication Date: 31 July 2024
Audience: College/higher education , Professional and scholarly , Primary , Undergraduate
Format: Hardback
Publisher's Status: Forthcoming

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.