ARTICLE | Regulation

Similar, slowly

Biosimilars: FDA plan points to slow iterative path; high analytical hurdles

February 13, 2012 8:00 AM UTC

Anyone who expected last week's release of FDA guidance documents on biosimilars to open the floodgates to U.S. approvals will be disappointed.

The path outlined in the documents is long, complex and iterative. High scientific hurdles and a case-by-case process will require manufacturers to closely collaborate with FDA and make substantial investments of time and money before they learn precisely what steps will be required to gain approval of a biosimilar...