Wednesday, 28 Jun 2017

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RheumNow Live Vote:
Biosimilars and Rheumatologists' Views
As biosimilar biologic agents become available, when will you use them?
How do you feel about using a biosimilar for psoriasis if it has only been tested in Crohn's colitis?
Monies saved using cheaper biosimilars should benefit whom?
How concerned are you about the safety of the biosimilar biologic agents?
anti-TNF biosimilars are approved and will soon be available. What info do you most need to prescribe a biosimilar? (choose one)
I am a:

RheumNow Live Vote:
Biosimilars and Rheumatologists' Views

As biosimilar biologic agents become available, when will you use them?
How do you feel about using a biosimilar for psoriasis if it has only been tested in Crohn's colitis?
Monies saved using cheaper biosimilars should benefit whom?
How concerned are you about the safety of the biosimilar biologic agents?
anti-TNF biosimilars are approved and will soon be available. What info do you most need to prescribe a biosimilar? (choose one)
I am a:


Rheumatologists' Comments

Comment: 
We have been told these biosimilars are not generics but they are “genetic biologics”! People would understand them better with such a thought. Generic small molecules are not the same as brand drugs. By FDA wording they are therapeutically equivalent and not pharmacologically equivalent. They are not tested in patients but in 24 to 36 normal volunteers with one dose to test the Area under the Curve and the CMax and compare it to the Brand. The generics have to within the curve of the brand drug and be no less than minus 20 and no more than plus 25They are therapeutically equivalent but not pharmaceutically equivalent - They are therapeutically equivalent. % - thus a 45 %guideline. Thus Generic drugs are not the same. They are therapeutically equivalent but not pharmaceutically equivalent - They are therapeutically equivalent in treatment. With Pharmaceutical Equivalents everything is the same The biosimilar is a more complex biologic generic and has many criteria to match the source biologic. They have a similar but an abbreviated biologic credentialing criteria similar to that for the source Biologic and have both preclinical and clinical criteria like a biologic but less in depth including pharmacokinetic and pharmacodynamics studies, animal studies, toxicology, immunologic testing etc. Like the generic small molecule the biosimilar generic is not the same drug but includes patient studies to show they are therapeutically equivalent but not pharmacologically equivalent using FDA criteria Our concern is are they truly therapeutically equivalent and can be used for extrapolation? These studies that bring them to market involve fewer patients. Furthermore safety is important. Genentech tested a humanized Rituxan without the chimeric for Rheumatoid Arthritis called Ocrelizumab but had safety concerns in Asia. In the studies it was very effective – my patients did very well. Thus the same pharmaceutical company that produced Rituxan did not develop a similar molecule for RA that they deemed was safe! (But now they are bringing in out for Multiple Arthritis!) For our confidence in the generic biologic the naming decision to have a 4 letter suffix that was void of meaning compounds our problems. I feel it should be representative of the company that developed it like generic biologic filgastrim-sndz that was developed by Sandoz. We should welcome very deep discounts of these generic biologics for our patients.