Biosimilar sales of $16+ billion were forecast in the EU and US alone for 2011.This estimate turned out to be 50-times too high. Does publication of the long-awaited guidance on the US Biologics Price Competition and Innovation Act mean a new dawn for biosimilars, or another false one? Written with the understandable detail and objectivity you need, Biosimilars:
- On the basis of several years market experience in Europe and Japan, where and with which biosimilars has most and least success been achieved, and why.
- Complexities of biological patents.
- The big controversies with biosimilars explained: Sourcing of reference products, similarity, naming, interchangeability, immunogenicity, traceability, indication extrapolation.
- Where payers incentivise usage of biosimilars.
- The importance of devices to administer biosimilars.
- Which companies are most active in biosimilar development, what are their targets and how far have they reached.
- Where biosimilar prospects are brightest through 2016
* Global: The situation in 27 developed and developing countries - across Europe, the Americas, Asia-Pacific and the Indian subcontinent
* Up-to-date: Includes 2011 sales data and February 2012 proposed FDA guidance
Rationale for biosimilars
Types of biosimilars
Lack of standardisation
2. Safety Concerns
Issues with biosimilars
Issues with originator products
For more information kindly visit :
Biosimilars : Current Situation & Future Prospects, Worldwide
Bharat Book Bureau
Tel: +91 22 27810772 / 27810773
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