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
Ref: Alvotech | Image: Alvotech
Related News:- Boehringer Ingelheim Reports the Commercial Availability of Cyltezo, an Interchangeable Biosimilar to Humira
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
