UPDATE: FDA approves another Humira biosimilar

The US Food and Drug Administration on Friday approved Cyltezo (adalimumab-adbm) for multiple indications as a biosimilar of AbbVie’s (NYSE: ABBV) Humira.

Adalimumab-adbm Cyltezo, from German family-owned pharma major Boehringer Ingelheim, is approved for multiple indications including treatment of adults with moderate-to-severe active rheumatoid arthritis.

This is the second FDA-approved biosimilar to US-licensed Humira, following Amgen’s (Nasdaq: AMGN) Amjevita (adalimumab-atto), which was cleared for marketing in September 2016. And, just last week, Samsung Bioepis gained European Commission approval for its Imraldi biosimilar of Humira. In March this year, Amgen also gained European approval for its biosimilar under the brand name Amgevita in March this year.