• Registered: Fri, 15 Oct 2010
  • Posts: 1,738

Topic: FDA Webinar: Biosimilar Biological Products after thought

Hi,  Lainy,

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.
God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

2 Reply by PCL1029 (edited by PCL1029 Tue, 17 Jul 2012 13:42:06)

  • Registered: Fri, 15 Oct 2010
  • Posts: 1,738

Re: FDA Webinar: Biosimilar Biological Products after thought

Hi,

that is why I don't quite get it in the FDA webinar below is their response to my questions:(the webinar is about biosimilars and biologics)

"Hi Percy,
Donna forwarded your questions to me and I sent them to Dr. Sherman.
Here is her response.
"The response to all his questions is that to date we have received no applications for a 351(k) product. "
Thanks for joining the webinar!
My questions to FDA are as follows:

"Hi, Donna,
1.where is the substitution list or interchangeability list that I can find for the "chemo biologics agents "such as Moabs and tyrosine kinase inhibitors?
2. is this webinar more gears to the cometics and orphan drugs(protein) eg vaccines and toxins   than the targeted agents used in the treatment of canner?
3.most of the targeted agents like sorafenib,erlotinib or bevacizumab and cetuximab,still have patents on them and most of them used "off the label" Is  this group of biologics included on the topics to day? if so how can we have a sub. list for drugs that still have patents on it in the pharmacy since the pathways of the above drugs are not quite similiar, isn't it.? Are they mostly entirely depending on the oncologist decision?
And  finally ,thanks Dr. sherman for this lecture.

God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

3 Reply by PCL1029 (edited by PCL1029 Tue, 17 Jul 2012 17:42:44)

  • Registered: Fri, 15 Oct 2010
  • Posts: 1,738

Re: FDA Webinar: Biosimilar Biological Products after thought

Hi, everyone,
if you want to know more about what is  biosimilar biological 351(k) products.
below is the link to learn more about it from FDA.

http://www.fda.gov/Drugs/DevelopmentApp … 291197.htm

so far as Dr.Sherman said ,no application received for 351(k) products.
I think this is a relatively new provision from the "Healthcare Affordable Act" signed by president Obama just 2 years ago and just passed by the supreme court last June, So  FDA is now ready for this.
The benefit  I think is to establish biological  product substitutions and thus ,in theory,using  biosimilar products to lower the cost instead of using  the expensive biological products like MoAb etc.
God bless.

God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.
  • Gavin
  • Gavin
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  • Registered: Tue, 23 Sep 2008
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Re: FDA Webinar: Biosimilar Biological Products after thought

Thanks for this Percy.