Biotech Values

[DewDiligence]

Re: FDA pathway for FoB’s

Further to Dr. Behrman’s talk mentioned in #msg-62559655:

Dr. Behrman explained that “analytics are the fundamentals.” This means that companies should use analytical techniques to characterize their biosimilar and try to prove that it's bioequivalent to the brand. Once FDA understands the analytics, they will determine “the extent of animal and human testing that will be necessary” on a case-by-case basis.

This echoes what Craig Wheeler has said on various occasions—compared to analytics, a clinical trial is a blunt instrument and will not be the main evidence to establish FDA approvability of an FoB.

In most cases, a clinical trial involving switching patients between the brand and the FoB will be required for an FoB to receive interchangeable status with its branded counterpart, but the switching trial can presumably be conducted after FDA approval with non-interchangeable status has been granted.

The quoted passage above comes from a sell-side research report. Sorry, I do not have a link.