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Pfizer's Abrilada (biosimilar- adalimumab) Receives the US FDA's Approval for Rheumatoid Arthritis

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Pfizer's Abrilada (biosimilar- adalimumab) Receives the US FDA's Approval for Rheumatoid Arthritis

Shots:

  • 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


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