Savitribai Phule Pune University, Pune

Jayakar Knowledge Resource Centre

Biosimilars development strategies : fast to market approaches / by Sarfaraz K. Niazi. English.

By: Niazi, Sarfaraz K [author.]Material type: TextTextPublication details: Boca Raton : CRC Press Taylor & Francis Group, 2025Edition: 1stDescription: viii, 187 p. ; 24 cmContent type: text Media type: computer Carrier type: online resourceSubject(s): Biosimilar Pharmaceuticals | Drug Development | Drug DesignAdditional physical formats: Biosimilars development strategiesDDC classification: 615.19 NLM classification: QV 241
Contents:
All About Biosimilars -- Product Type and Selection Strategies -- Development Master Plan -- Optimization of Cost of Goods -- Strategic Understanding for Biosimilars Future -- Repurposing Biosimilars.
Summary: "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"-- Provided by publisher.
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Item type Current library Home library Call number Status Notes Date due Barcode Item holds
Books Jayakar Knowledge Resource Centre
Jayakar Knowledge Resource Centre
615.19 NIA.S (Browse shelf(Opens below)) Available 120.00 Pound 523039
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Includes bibliographical references and index.

All About Biosimilars -- Product Type and Selection Strategies -- Development Master Plan -- Optimization of Cost of Goods -- Strategic Understanding for Biosimilars Future -- Repurposing Biosimilars.

"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"-- Provided by publisher.

Description based on print version record and CIP data provided by publisher.

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