Biosimilars Development Strategies
Fast to Market Approaches
Inbunden, Engelska, 2024
2 096 kr
Beställningsvara. Skickas inom 10-15 vardagar. Fri frakt över 249 kr.
Fler format och utgåvor
Beskrivning
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.
Produktinformation
Utforska kategorier
Mer om författaren
Innehållsförteckning
Hoppa över listan
Du kanske också är intresserad av
- 10% rabatt på allt
- 10% rabatt på allt
Del 3
- 10% rabatt på allt
Del 11
- 10% rabatt på allt
Del 4
- -30%
- 10% rabatt på allt
Del 7
- 10% rabatt på allt
Del 4