The potential benefits that biosimilars offer are well celebrated through providing improved patient access to affordable, effective and complex treatments. The demand for affordable treatments in the face of escalating healthcare costs is high but a number of hurdles present themselves when bringing a biosimilar from bench to market. In this rapidly changing marketplace with its recently implemented and still evolving regulatory framework, it is critical to adopt the right strategy, overcome barriers to entry and stay ahead of the game.
The starting point is to have a solid understanding of biosimilar development and the clinical trials environment. We asked some industry and regulatory experts to provide their opinion on best practice in biosimilar development, manufacturing and clinical stages. Take a look at what they had to say.
Reasons to download:
- Learn what the current hurdles are in biosimilar development and how they can be overcome
- Discover different organization’s approaches to biosimilar development
- Understand the key takeaways from the FDA draft guidance
If you are interested in biosimilar product development, you may like to attend Biosimilar Drug Development World Americas 2013.