Alvotech and STADA Report EMA Acceptance of MAA for AVT04, a Proposed Biosimilar to Stelara (ustekinumab)
Shots:
- The EMA has accepted a MAA of AVT04, a proposed biosimilar to Stelara (ustekinumab). The EMA opinion on AVT04 will be expected in H2’23
- Alvotech’s focus is to provide patients access to more affordable biologics globally while the end-to-end biosimilars platform will support the development and manufacture of multiple products
- In May 2022, Alvotech highlighted the confirmatory clinical, safety & efficacy study of AVT04 that met its 1EPs & showed therapeutic equivalence b/w Alvotech’s biosimilar candidate and the reference product for the treatment of chronic plaque-type psoriasis. Alvotech also reported the PK similarity study results of AVT04
Ref: Globenewswire | Image: Alvotech
Related News:- Alvotech and Teva Reports the US FDA’s Acceptance of BLA for Review of AVT04, a Proposed Biosimilar to Stelara (ustekinumab)
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