Alvotech has announced that, “as expected”, its US filing for its AVT04 ustekinumab candidate has resulted in a complete response letter from the FDA over manufacturing facility deficiencies, following similar knockbacks for its adalimumab biosimilar. However, the firm anticipates an inspection and a new goal date for the proposed Stelara rival long before its planned February 2025 launch date.
After multiple complete response letters from the US Food and Drug Administration relating to its AVT02 adalimumab biosimilar candidate, linked to manufacturing deficiencies at its Reykjavik facility, Alvotech has now revealed a similar fate for its AVT04 version of Stelara (ustekinumab).
“The FDA has issued a CRL for Alvotech’s biologics license application for AVT04,” Alvotech announced. “As expected, the CRL noted...
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
Stada’s Specialty division was boosted by the firm’s launch last year of a European Stelara biosimilar, even as generics growth remained muted in Q1.
Formycon is preparing to start a new era – entering Latin America with its ranibizumab biosimilar, which is expected to be a “good contributor” to the firm’s finances.
