Alvotech announced positive topline results from a confirmatory clinical study for AVT05, Alvotech's proposed biosimilar to Simponi and Simponi Aria(golimumab). Alvotech is the first company to announce positive topline results of a clinical trial using a proposed biosimilar to Simponi and Simponi Aria and is one of only two companies known to have initiated such a patient study. The primary outcome measure is change from baseline to week 16 in DAS28-CRP, which is a disease activity score measurement for rheumatoid arthritis.

The study met its primary endpoint, with results demonstrating therapeutic equivalence between AVT05 and Simponi. Additionally, no clinically meaningful differences in safety were observed through week 24. In November 2023Alvotech announced positive to pline results from a pharmacokinetic study (NCT05632211) for AVT05, which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to EU approved Simponi and US-licensed Simponi in 336 healthy adult subjects.

All three study treatments were given at a single dose of 50 mg/0.5 mL pre-filled syringe, via a subcutaneous injection. Alvotech's commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co. Ltd. (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co.

Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co. Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories.

Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners.