Alvotech Announces Ongoing Studies of its Proposed HUMIRA Biosimilar

Earlier this week, Alvotech announced that it has completed enrollment of its Phase III study of AVT02,  its proposed biosimilar of Humira® (adalimumab).  The study has enrolled 407 patients with moderate-to-severe chronic plaque psoriasis and will occur across approximately 30 sites in Europe “to compare AVT02 and Humira® in terms of safety, efficacy, tolerability and immunogenicity” in this patient population.  Alvotech is also conducting a Phase I pharmacokinetics comparability study, as well as clinical studies related to its autoinjector.  Dr. Fausto Berti, Alvotech’s Senior Vice President and the head of clinical and late stage development, stated that Alvotech will report top-line results regarding the primary endpoint in early 2020, along with data from its Phase I PK study.

According to Alvotech’s announcement, “AVT02 contains a high concentration (100 mg/ml) formulation, which is expected to be more convenient for patients” and “position[s] [Alvotech] to differentiate itself from other biosimilars in the market.”  The reference product is approved by the U.S. FDA in multiple dosage forms and strengths, each being either 50 mg/ml or 100 mg/ml formulations. To date, all FDA-approved adalimumab biosimilars (Amgen’s AMJEVITA, Boehringer Ingelheim’s CYLTEZO, and Sandoz’s HYRIMOZ) all are 50 mg/ml formulations.