Alvotech Reports Results of AVT02 (a proposed biosimilar to adalimumab) in Two Clinical Studies for Autoimmune Diseases

Alvotech, Reports, Results, AVT02, proposed biosimilar, HUMIRA, (adalimumab), Two, Clinical Studies, Autoimmune Diseases

Shots:

  • The P-I AVT02-GL-101 study compares the PK, safety and tolerability of AVT02 to EU & US Humira and the PK of EU and US-Humira following a 40mg (SC) inj. in 392 healthy volunteers. The study has met its 1EP i.e. all PK endpoints are within the equivalence margins for all pairwise comparisons and demonstrated PK similarity of AVT02 to the HUMIRA
  • The P-III AVT02-GL-301 study assess AVT02 vs Humira in 412 patients with mod.-to-sev. chronic plaque psoriasis. The study met its 1EPs by demonstrating equivalent efficacy as measured by the PASI improvement @16wks.
  • AVT02 is mAb, a proposed biosimilar to HUMIRA (adalimumab) with high concentration (100mg/mL) dosage forms

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