Teva's Partner Alvotech Receives Complete Response Letter on the BLA of AVT02 (biosimilar, adalimumab)
Shots:
- The US FDA has issued a CRL to its partner Alvotech for the BLA of AVT02, a high-concentration biosimilar candidate for Humira (adalimumab)
- The application could not currently be approved due to issues with Alvotech's manufacturing facility that need to be satisfactorily resolved. To determine the next steps., additional review of the details, following the recent FDA re-inspection and CRL are being assessed
- The US FDA is still reviewing Alvotech's second BLA for AVT02 incl. data to support approval as a biosimilar & additional information supporting interchangeability designation & BsUFA goal date is expected on June 2023. AVT02 is currently marketed in 16 countries in the EU & Canada
Ref: Businesswire | Image: Teva
Related News:- Alvotech and Bioventure Receive the SFDA’s Approval of AVT02 (biosimilar, adalimumab) in Saudi Arabia
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