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£138 today · previous high £138 · all-time low £129

CRC Press Biosimilars Development Strategies: Fast to Market Approaches

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£138.44 £128.08 £130.34 £132.60 £134.86 £137.12 £139.38 25 July 2026 31 July 2026 07 August 2026 14 August 2026 21 August 2026
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Price range: £129 - £138

Price levels: 3 different prices over 28 days

Description
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.

Product Specifications
Brand
CRC Press
Format
hardcover
ASIN
1032517018
Category
Books > Subjects > Business, Finance & Law > Law > European Union (EU)
Domain
Amazon UK
Release Date
15 July 2024
Listed Since
25 January 2024

Barcode

No barcode data available

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