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DewDiligence

06/24/13 2:53 PM

#162991 RE: DewDiligence #162988

NVS isn’t conceding that the Enbrel FoB won’t play in the US market, but I consider that a bluff; from the company’s own PR:

http://www.sandoz.com/media_center/news/2013/press_releases/2013_06_24_phase_III_biosimilar_etanercept.shtml

The global clinical trial will seek to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis. The global clinical program was developed in consultation with regulatory authorities in the U.S. and EU, and the results from this clinical trial are expected to support regulatory submissions in both the U.S. and EU [really?].

That the indication for the FoB is psoriasis rather than RA doesn’t eliminate the patent roadblock in the US, IMO.