The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.

The latest figures on uptake of rivals to AbbVie's Humira in the US show adalimumab biosimilars beginning to capture significant market share from the originator after an initially slow start in 2023.

Driven by increased orders, Alvotech is bullish on its US adalimumab biosimilar moving into 2025, as it also look forward to the US launch for its Stelara biosimilar early next year.

Regeneron’s Eylea 8mg, which offers less frequent dosing and is intended to act as a bulwark against biosimilar competition to the originator’s earlier 2mg version, is a target for biosimilar sponsor Alvotech. The Icelandic firm is aiming to lead the way in global markets.