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FDA Approves Tocilizumab-Anoh as a Biosimilar to Actemra
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Key Takeaways
- Tocilizumab-anoh (Avtozma) is approved for intravenous and subcutaneous administration for multiple diseases, including rheumatoid arthritis and COVID-19.
- The FDA's approval is based on comprehensive data and evidence, including a phase 3 study.
The approval includes indications for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.
This is an ongoing story.
The FDA approved tocilizumab-anoh (Avtozma; Celltrion), a biosimilar to tocilizumab (Actemra; Genentech), as both an intravenous and subcutaneous formulation to treat multiple diseases, including rheumatoid arthritis (RA), giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.
The drug is indicated for imultiple diseases, such as rheumatoid arthritis (RA), giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.| Pawel | stock.adobe.com
The FDA approval is based on comprehensive data and totality of evidence, which included a phase 3 study demonstrating the biosimilarity between the biosimilar and the reference product for patients with moderate to severe active RA.
