While Boehringer Ingelheim Pharmaceuticals Inc. is the second company to win US approval of a biosimilar to AbbVie Inc.'s Humira (adalimumab), its launch date is uncertain given ongoing patent infringement litigation.
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.

More from Biosimilars
More from Biosimilars & Generics
The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.
Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?
The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.