The Future of Biosimilars: Addressing Regulatory Challenges

May 13, 2014 10:57 AM


Life Science Training Institute is organizing an online training course about biosimilars on June 19, 2014. 

The Biologics Price Competition and Innovation Act (BPCIA) of 2010 (“Biosimilar Act”) serves as FDA’s current framework for biosimilars, but there is a great of deal confusion surrounding this legislation and regulatory pathways for approval.  Many companies that have plans to enter the biosimilars market are awaiting direction on how to proceed. FDA plans to release new documents in 2014 that will further define compliance and signal the development of new therapies as patents for innovator biopharmaceutical products approach expiration.

This 90-minute online course will give you the tools to bring your products to market in a swift and compliant manner.  Examples of successful and unsuccessful submissions will be discussed, as well as major differences between US and EMA regulations and World Health Organization guidelines.

If you want to attend this conference, you can find more information on http://www.lifesciencetraininginstitute.com/doc/the-future-of-biosimilars-addressing-regulatory-challenges-0001

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