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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