£88.12

This is the most expensive it has ever been. Walk away.

£88 today · previous high £88 · all-time low £87

CRC Press Biosimilarity: The FDA Perspective - Drug Approval Guide

Amazon

Price History & Forecast

Grey patches = out of stock. Cheaper = lower on the chart. Hover for exact prices.

Last 71 days · 71 data points (no recent data)

Historical
Generating forecast…
£88.12 £86.66 £86.98 £87.30 £87.61 £87.93 £88.25 28 July 2026 14 August 2026 01 September 2026 18 September 2026 06 October 2026
View at Amazon ↗

Price data last checked 20 day(s) ago - will refresh soon

NEW HERE?

Amazon shows you one price. We show you all of them.

Tosheroon watches Amazon prices so you don't have to. Every product on Amazon has a price history — we make it visible. Set the price you'd actually pay, and we'll email you the second it gets there. No app, no account, one email.

WHAT'S ON THIS PAGE

↑ Price chart
when this has been cheap or pricey
↑ Forecast
where the price is heading next
↓ Statistics
all-time high & low, recent range
↑ Price alert
name your number, we'll email you

Price Distribution

Price distribution over 71 days • 2 price levels

Days at Price
Current Price
44 days 27 days · current 0 11 22 33 44 £87 £88 Days at Price

Price Analysis

Most common price: £87 (44 days, 62.0%)

Price range: £87 - £88

Price levels: 2 different prices over 71 days

Description

Biosimilarity: The FDA Perspective by CRC Press is a comprehensive guide to understanding how the U.S. FDA approves biosimilar drugs, drawing directly from recent real-world FDA approval decisions. This authoritative resource examines the statutory limitations and non-inferiority testing methodologies that allow developers to reduce patient trials and minimise immunogenicity testing requirements. The book provides an in-depth scientific, mathematical and statistical analysis of the tools and approaches necessary to establish biosimilarity across biological drugs of varying complexity. Essential for biosimilar developers, regulatory professionals and biomedical engineers seeking practical insights into FDA approval pathways, this work combines theoretical knowledge with case studies from actual approval packages to guide successful drug development strategies.

Key Features

CRC Press provides comprehensive analysis grounded in actual FDA guidelines and approval packages from multiple biosimilar products.

Covers non-inferiority testing methodologies designed to reduce the need for extensive patient trials in biosimilar development.

Examines immunogenicity testing approaches and strategies to minimise unnecessary testing whilst maintaining safety standards.

Includes scientific, mathematical and statistical frameworks essential for establishing biosimilarity across different biological drug complexities.

Addresses statutory limitations affecting biosimilar approval, offering practical solutions for regulatory compliance.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
04 August 2016
Listed Since
04 November 2015

Barcode

No barcode data available

Similar Products You Might Like

Biosimilars and Interchangeable Biologics: Strategic Elements
98% match

Biosimilars and Interchangeable Biologics: Strategic Elements

CRC Press

Price unavailable
CRC Press Biosimilars Development Strategies Book
98% match

CRC Press Biosimilars Development Strategies Book

CRC Press

£138.44 21 Aug 2026
Biosimilars and Interchangeable Biologics: Tactical Elements
98% match

Biosimilars and Interchangeable Biologics: Tactical Elements

CRC Press

£184.58 09 Sep 2026
Biosimilars and Interchangeable Biologics: Strategic Elements
98% match

Biosimilars and Interchangeable Biologics: Strategic Elements

CRC Press

£114.65 24 Sep 2026
Biosimilars and Interchangeable Biologics: Tactical Elements
97% match

Biosimilars and Interchangeable Biologics: Tactical Elements

CRC Press

£54.70 18 Sep 2026
Biosimilars: A New Generation of Biologics
97% match

Biosimilars: A New Generation of Biologics

Springer

£85.76 22 Sep 2026
Biosimilars: A New Generation of Biologics
97% match

Biosimilars: A New Generation of Biologics

Springer

£88.21 21 Sep 2026
Biosimilar Drug Product Development - CRC Press Guide
97% match

Biosimilar Drug Product Development - CRC Press Guide

CRC Press

£135.35 06 Oct 2026
ASHP Biosimilars and Biologics - Healthcare Implementation Guide
97% match

ASHP Biosimilars and Biologics - Healthcare Implementation Guide

American Society of Health-System Pharmacists

£123.00 03 Oct 2026
Biosimilar and Interchangeable Biologics: From Cell Line to Commercial Launch, Two Volume Set
97% match

Biosimilar and Interchangeable Biologics: From Cell Line to Commercial Launch, Two Volume Set

CRC Press

£322.84 19 Aug 2026
Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics
97% match

Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics

Elsevier

£110.99 09 Sep 2026
Biosimilar Drug Product Development (Drugs and the Pharmaceutical Sciences)
97% match

Biosimilar Drug Product Development (Drugs and the Pharmaceutical Sciences)

CRC Press

£71.90 21 Aug 2026
Biologics and Biosimilars: Drug Discovery and Clinical Applications
97% match

Biologics and Biosimilars: Drug Discovery and Clinical Applications

CRC Press

£45.99 03 Sep 2026
Biosimilar Clinical Development: Scientific Considerations and New Methodologies (Chapman & Hall/CRC Biostatistics Series)
97% match

Biosimilar Clinical Development: Scientific Considerations and New Methodologies (Chapman & Hall/CRC Biostatistics Series)

CRC Press

£95.60 23 Sep 2026
Commercialization of BioPharma Products in the USA (BW): A Practical Guide
96% match

Commercialization of BioPharma Products in the USA (BW): A Practical Guide

Rxcommercial Research International, Incorporated

£160.70 08 Sep 2026
Biologics, Biosimilars, and Biobetters: An Introduction for Pharmacists, Physicians and Other Health Practitioners
96% match

Biologics, Biosimilars, and Biobetters: An Introduction for Pharmacists, Physicians and Other Health Practitioners

Wiley

£100.27 07 Oct 2026
Analytical Similarity Assessment in Biosimilar Product Development
96% match

Analytical Similarity Assessment in Biosimilar Product Development

CRC Press

£170.72 24 Sep 2026
Follow-On Biologics: Background & Issues (Biotechnology in Agriculture Industry and Medicine)
96% match

Follow-On Biologics: Background & Issues (Biotechnology in Agriculture Industry and Medicine)

£95.06 25 Sep 2026
Benefit-Risk Assessment in Pharmaceutical Research and Development (Chapman & Hall/CRC Biostatistics Series)
96% match

Benefit-Risk Assessment in Pharmaceutical Research and Development (Chapman & Hall/CRC Biostatistics Series)

CRC Press

£75.00 17 Sep 2026
Artificial Intelligence for Drug Product Lifecycle Applications
96% match

Artificial Intelligence for Drug Product Lifecycle Applications

Elsevier

£131.99 25 Aug 2026
Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead
96% match

Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead

CRC Press

£75.18 13 Sep 2026
Mastering Strategic Marketing For Specialty Pharmaceuticals: A Hands-on Guide
96% match

Mastering Strategic Marketing For Specialty Pharmaceuticals: A Hands-on Guide

World Scientific Publishing Company

£28.32 21 Aug 2026
Development and Evaluation of Drugs: From Laboratory through Licensure to Market
96% match

Development and Evaluation of Drugs: From Laboratory through Licensure to Market

CRC Press

£160.24 28 Aug 2026
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
96% match

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Springer

£144.69 22 Oct 2026