Humira Biosimilar: Boehringer Faces Same Launch Hurdles As Amgen
AbbVie seeks injunction against Boehringer Ingelheim's Cyltezo claiming infringement of 74 patents, 8 of which are in the initial round of litigation; as of Aug. 2, BI had not given 180-day launch notice.
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Boehringer Ingelheim has welcomed a new FDA approval for its Cyltezo (adalimumab-adbm) interchangeable biosimilar, ahead of planned launch on 1 July.
US Approvals Roundup: Cyltezo Biosimilar, Victoza CV Benefit, Gocovri In PD, Kedrab Rabies Biologic, Gout Combo Duzallo
FDA's clearances showcase the application of formulation technology to reduce problem side effects and improve convenience of available drugs.
Boehringer Ingelheim announcement is first public disclosure of interchangeability trial since US FDA draft guidance was released.