On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab). The clinical study will compare the efficacy, safety, and immunogenicity of AVT05 and Simponi in adult patients with moderate to severe rheumatoid arthritis. Per the announcement,…
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year: USPTO Outlines New Initiatives Regarding Drug Pricing In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published a letter summarizing several…
Luye Pharma Group announced last week that China’s National Medical Products Administration has approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of fractures. Luye Pharma Group, in conjunction with its subsidiary Boan Biotech, is now the first company in the world to receive…