Blog Big Molecule Watch December 01, 2017

FDA Webinar To Discuss the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.

Next Tuesday (December 5) between 1:00-2:30pm (EST), FDA’s Division of Drug Information is presenting a webinar titled an “Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.”  The webinar will provide an overview of the regulatory framework for biosimilar products, “including a background, information on terminology and the general requirements of the approval pathway for biosimilars.”  According to the announcement, other topics will include the difference between biosimilar and interchangeable products and how they are prescribed/dispensed, how FDA assesses analytical similarity, and the role of clinical studies in the biosimilar development process.

For more information and to register, click here.

The post FDA Webinar To Discuss the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S. appeared first on Goodwin Procter BioSimilars Blog.