Shots:
- The company has launched Simlandi (citrate-free biosimilar, Humira) injection to treat RA, PsA, AS, UC, Plaque Pso, HS, uveitis, juvenile idiopathic arthritis & CD in the US
- The US FDA has approved Simlandi (40mg/0.4mL) injection. Both the low & high concentrations dosing strengths are approved and marketed across the US
- 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
Ref: Globenewswire | Image: Teva & Alvotech | Press Release
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