Friday, June 28, 2013

Session Spotlight: Update on United States Biosimilars Program

Because of the recently defined regulatory pathways for biosimilars, there has been a huge rise in the number of biosimilar products in development.Thorough characterization of a biosimilar candidate in comparison with the reference product is the basis for a targeted clinical development program. FDA biosimilar guidelines suggest not only to analyze isolated quality attributes but also to focus on combinations of quality parameters. So what is the current status?

Session: FDA Perspective - Update on the United States Biosimilars Program

Speaker: Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), CDER, US FDA

Want to learn more about emerging technical considerations to assure safe and efficacious biosimilar products? Join us October 21-23 in Washington, DC for the 17th Annual Well Characterized Biologicals event.

To learn more, download our brochure. Register today for the leading industry conference to provide multiple, detailed case studies of the challenges, strategies and technologies involved in characterization and comparability of new biological molecules. We look forward to seeing you this fall!

As a reader of this blog, you'll receive 20% off the standard rate when you mention the discount code XB13193BLOG to register.

Share this article with your social network, just click below to share now!

No comments :

Post a Comment