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iwfal

02/23/12 12:12 AM

#137642 RE: DewDiligence #137631

Presumably not for US market due to AMGN’s recent patent extension.



Why do you say that - at the macro level I'd suggest that there is a good chance that the AMGN patent can be invalidated. ?
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DewDiligence

02/13/13 4:59 PM

#156935 RE: DewDiligence #137631

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DewDiligence

11/25/13 5:37 PM

#170499 RE: DewDiligence #137631

MYL-Biocon get India’s approval for Herceptin FoB:

http://finance.yahoo.com/news/mylan-biocon-receive-first-indian-153000715.html
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DewDiligence

06/03/16 2:26 PM

#201764 RE: DewDiligence #137631

MYL/Biocon present Herceptin-FoB data at ASCO:

http://finance.yahoo.com/news/mylan-biocon-present-phase-3-180000878.html
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DewDiligence

11/08/16 8:59 AM

#205837 RE: DewDiligence #137631

MYL/Biocon submit 351(k) application for Herceptin FoB:

http://finance.yahoo.com/news/mylan-biocon-announce-u-fda-123000423.html
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DewDiligence

06/04/18 5:47 PM

#219390 RE: DewDiligence #137631

FDA approves MYL’s Fulphila—a Neulasta FoB:

https://www.prnewswire.com/news-releases/us-fda-approves-mylan-and-biocons-fulphila-pegfilgrastim-jmdb-the-first-biosimilar-to-neulasta-300659410.html

Neulasta is a tricky drug for FoBs to match due to its unusual pharmacokinetics. This is the first successful attempt in the US after a couple of failures (NVS, CHRS).