CHMP gives positive approval for Boehringer Ingelheim’s AmAb

by Bioblast Editor | Sep 15, 2017 | Biosimilars updates

BI receives positive CHMP opinon on Cyltezo®, biosimilar to adalimumab. Approval is expected in Q4/17.

Sandoz announces 51 week results for AmAb biosimilar

by Bioblast Editor | Sep 14, 2017 | Biosimilars updates

Sandoz announces at the EADV results from 51 week clinical study confirming that Sandoz’s biosimilar adalimumab matches Humira® in safety and efficacy profile.

PTAB denies institution of Coherus’ IPR petitions

by Bioblast Editor | Sep 7, 2017 | Biosimilars updates

PTAB denies institution of Coherus Biosciences’ 4 IPR petitions against AbbVie’s 9,085,619 relating to the Humira® formulation.

FDA approves Cyltezo®

by Bioblast Editor | Aug 29, 2017 | Biosimilars updates

Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for Cyltezo® (adalimumab-adbm), a biosimilar to Humira®. This is the first biosimilar from BI to be FDA approved. According to the release: Cyltezo® is not yet commercially available due to the active...

EMA approves Imraldi®

by Bioblast Editor | Aug 24, 2017 | Biosimilars updates

Imraldi®, Biogen/Samsung’s adalimumab biosimilar approved in the EU.