- The US FDA approval is based on the clinical study assessing Abrilada (adalimumab-afzb) vs reference product, AbbVie’s Humira in 597 biologic-naïve patients with rheumatoid arthritis for 78 wks.
- Result: @26wks. patients achieved ACR20 (68.7% vs 72.7%) with a treatment difference of −3.98%, ACR20, 50, and 70 rates were similar with both groups
- The approval of Abrilada, a biosimilar to Humira foster the biologics competition in the US as it marks the 9th biosimilar product to be approved in the US in 2019, bringing the overall total of biosimilar approvals to 25
Click here to read full press release/ article | Ref: FDA | Image: Financial Express