Skip to content Skip to footer

Alvotech and Teva’s Simlandi (Biosimilar, Humira) Receives the US FDA’s Approval for the Treatment of Multiple Indications 

Shots: 

  • The US FDA has approved Simlandi injection for treating adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa & uveitis as well as juvenile idiopathic arthritis & Crohn’s Disease 
  • The approval was based on a series of studies incl. P-I (AVT02-GL-101) trial comparing the PK, safety & tolerability in healthy adults and two P-III (AVT02-GL-301 & AVT02-GL-302) studies comparing the PK, efficacy, safety & immunogenicity of Simlandi vs Humira to treat moderate-to-severe chronic plaque psoriasis 
  • Teva is responsible for the exclusive commercialization of Simlandi across the US under a strategic collaboration with Alvotech 

4Ref: Alvotech & Teva| Image: Alvotech and Teva | Press Release

Related News:- Celltrion Reports the MAA Submission to the MFDS Korea for CT-P47 (biosimilar, tocilizumab) to Treat Various Indications 

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

Sign Up to Our Newsletter

Be the first to know the latest updates

[mc4wp_form id="13387" element_id="style-1"]