Topic: FDA Webinar: Biosimilar Biological Products after thought
Thanks for your compliment. Actually Eli is doing most of the work. I just join him to add a little that I know.
Have you write anything on the here about your adventure with the GrandKids?
I cannot find any.
I have just finished A FDA webinar about biosimilars vs biologics . they talked about interchangeability and substitutions. and the passage of the Biologics User Fee Act of 2012(BsUFA); Well let me put it in this way, the only thing I get out from the webinar is that ,if the biologics(ie:MoAb,small molecular proteins) is not on the substitution list,the insurance companies will NOT pay for the substitution or the interchangeability if no clinical data proof of the usefulness of the substitution.But where is the list and how I can get a copy for this message board?;I guest I have to email to the presenter.The people who called in asking completely different questions like co-enzyme Q ,Spanish translation patient package insert(PPI);why USA is slow in catching up of the substitution policy as compare to EUROPE? I think they are talking about more on the cosmetics side or OTC drugs in the FDA ( The food and drugs and cometics act) law than chemotherapy alone. then again,who knows.