The US Food and Drug Administration (FDA) has granted approval to Iceland-based Alvotech’s (NASDAQ: ALVO) Simlandi, marking it as the first interchangeable high-concentration, citrate-free biosimilar to AbbVie’s (NYSE: ABBV) immunosuppressant Humira (adalimumab). Humira faced patent expiration in the US last year, leading to biosimilar competition. Simlandi is approved for various indications, including adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa, and adult uveitis.
Benefiting from the fact that the majority of US prescriptions for adalimumab are for high-concentration formulations, Simlandi’s 40mg/0.4ml injection has gained interchangeable exclusivity. This allows for automatic substitution at the pharmacy level without the need for prescriber consultation.
Alvotech’s biosimilar entry will be commercially marketed in the US by its partner Teva (NYSE: TEVA).- Flcube.com
