Road To Biosimilar Interchangeability Could Be Through Market Experience
Executive Summary
Demonstrating that a biosimilar is interchangeable with its reference product may be a subject for post-market studies rather than clinical trials, according to Kathleen Sanzo, partner at Morgan, Lewis and Bockius
You may also be interested in...
Biosimilars May Drift, But What Should FDA Do About It?
Another balance FDA likely will have to strike in its emerging biosimilars pathway is letting innovators improve and update manufacturing processes while ensuring similar biologics can remain similar to their reference products.
Biosimilars May Drift, But What Should FDA Do About It?
Another balance FDA likely will have to strike in its emerging biosimilars pathway is letting innovators improve and update manufacturing processes while ensuring similar biologics can remain similar to their reference products.
FDA Creates Biosimilars Overseer In Drug Office; Internal Panel To Advise Application Reviewers
Leah Christl brings molecular and cellular biology background to the job of implementing an approval pathway for biosimilars.