The FDA has announced a public advisory committee meeting to discuss a biologics license application for a proposed biosimilar to Janseen Biotech Inc.’s Remicade submitted by Celltrion, Inc.
The meeting will be held on Tuesday, March 17, 2015 from 8 am to 5 pm in the Great Room at the FDA White Oak Campus. This is a significant milestone since it is the first biosimilar monoclonal antibody application to be reviewed by the Arthritis Advisory Committee.
In the announcement, the FDA invites public testimony.
If you would like to make a formal oral presentation please notify Stephanie Begansky at AAC@fda.hhs.gov or 301-796-9001 no later than Monday, February 23, 2015.
If you would like to submit written comments please reply to Stephanie Begansky at AAC@fda.hhs.org no later than Tuesday, March 3, 2015.
See the notice here.