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zipjet

06/27/17 8:47 AM

#212120 RE: DewDiligence #212115

a product won’t be eligible for FDA interchangeable status unless the sponsor has the analytical tools to prove a high degree of sameness to the reference brand.



Sounds like another reason some company should acquire MNTA.
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DewDiligence

06/27/17 5:05 PM

#212136 RE: DewDiligence #212115

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DewDiligence

07/27/17 2:03 PM

#212702 RE: DewDiligence #212115

(MNTA)—B-I starts switching study for Humira FoB:

http://www.businesswire.com/news/home/20170727005789/en/Boehringer-Ingelheim-starts-clinical-study-interchangeability-adalimumab

The point of a switching study is to seek FDA interchangeable status.