The US FDA has approved Riabni, a biosimilar to Rituxan in combination with methotrexate for adults with mod. to sev. active RA who had an inadequate response to ≥1 TNF antagonist therapies
The clinical study evaluates Riabni (CD20-directed cytolytic Ab) vs rituximab in 311 patients with RA. The primary efficacy EPs is the change in DAS28-CRP from baseline @24wk. The results were within the predetermined equivalence margin indicating that the two therapies were clinically equivalent & were similar in terms of safety, PK & immunogenicity
Riabni was approved to treat NHL, CLL, GPA & MPA in adult patients. The company’s portfolio includes 11 biosimilars that could be used to treat CID & cancer including 5 US & 3 EU-approved biosimilars
Ref: Amgen | Image: Amgen
