JNJ - Alvotech: Initiating With Hold Rating On FDA CRL AVT05 And Reduced EBITDA Guidance
2025-11-03 14:07:04 ET
I'm initiating Alvotech ( ALVO ) with a Hold rating because, while it has several biosimilars approved, like the biosimilar to Humira (adalimumab) in the U.S. of Simlandi (AVT02) and the biosimilar to Stelara (ustekinumab) in the U.S. of Selarsdi, it had to cut its revenue outlook for full-year 2025. Such a cut in revenue guidance for full-year 2025 was done so because the company received a Complete Response Letter ((CRL)) from the FDA for its biosimilar candidate to Simponi (golimumab) AVT05. This is disappointing because this biosimilar, being advanced by the company, targets a variety of types of arthritis, which I will be going over below. I believe that this CRL can be fixed quickly, though, because it was stated that the reason for being given it was due to a pre-license inspection of a manufacturing facility where deficiencies were found....
Alvotech: Initiating With Hold Rating On FDA CRL AVT05 And Reduced EBITDA Guidance