Biosimilars Development Strategies

Download or read book Biosimilars Development Strategies written by Sarfaraz Niazi and published by . This book was released on 2025 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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"--