Stelara Biosimilar Gets ‘Complete Response’

FDA has issued Alvotech a complete response letter for its BLA for AVT04, a biosimilar of Janssen’s Stelara (ustekinumab). The letter cited “certain deficiencies” that were documented during an FDA March inspection of the company’s Reykjavik facility in Iceland, an Alvotech release says. “No other deficiencies in the application were noted by the FDA,” it says. “Alvotech intends to resubmit the BLA for AVT04 to the FDA shortly, which would likely trigger a six-month review period and a new Biosimilar User Fee Act (BsUFA) goal date… Based on our latest interactions with the FDA we are currently expecting that the agency will reinspect our facility in the beginning of next year.”

Stelara is approved for treating certain patients with moderate to severe psoriasis, active psoriatic arthritis, moderate to severe active Crohn’s disease, and moderate to severe active ulcerative colitis.