Alvotech and Bioventure Receive the SFDA’s Approval of AVT02 (biosimilar, adalimumab) in Saudi Arabia
Shots:
- SFDA has approved AVT02, an adalimumab biosimilar referencing Humira for manufacturing & distribution in Saudi Arabia for RA & other inflammatory diseases
- In Saudi Arabia, the biosimilar will be marketed under the name Simlandi. AVT02 is currently under the US FDA’s review with a manufacturing facility inspection scheduled for March 2023 & decision date of Apr 2023
- Under the license agreement for AVT02, Alvotech will lead the development & manufacturing while Bioventure will be responsible for the commercialization of the biosimilar. AVT02 is a mAb & approved biosimilar to Humira & has been approved in the 27 countries of the EU, Norway, Iceland, Liechtenstein, the UK & Switzerland as Hukyndra; in Australia as Ciptunec/Ardalicip & in Canada as Simlandi
Ref: Alvotech | Image: Alvotech
Related News:- Alvotech and Cipla Receive Marketing Authorization for AVT02 (biosimilar, adalimumab) in Australia
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
