Alvotech and Teva announce filing acceptance of US biologics license applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab)

Alvotech

27 January 2025 - Alvotech and Teva Pharmaceuticals today announced that the US FDA has accepted for review biologics license applications for AVT05, Alvotech’s proposed biosimilar to Simponi and Simponi Aria (golimumab), which are prescribed to treat a variety of inflammatory conditions. 

These are the first US BLA filing acceptances announced for a biosimilar candidate to golimumab.

Read Alvotech press release

Michael Wonder

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Michael Wonder

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Medicine , US , Biosimilar , Dossier