During its investor call on 22 April 2026, Amneal confirmed that, following its acquisition of Kashiv Biosciences, it is expecting to have 6 biosimilars launched in the US by 2027. This includes:
- biosimilars that are already on the market: Alymsys® (bevacizumab) (FDA-approved April 2022, referencing Avastin®), Releuko® (filgrastim) (FDA-approved March 2022, referencing Neupogen®), Fylnetra® (pegfilgrastim) (FDA-approved May 2022, referencing Amgen’s Neulasta®); and
- those which are yet to launch: Boncresa™ and Ozilutus™ (denosumab) (FDA-approved December 2025 in partnership with mAbxience, referencing Amgen’s Prolia® and Xgeva®) and omalizumab biosimilar, ADL018 (FDA approval pending, under licence with Alvotech, referencing Genentech/Novartis’ Xolair®).
Amneal is also expecting approvals for 6+ advanced pipeline biosimilar products in 2028-2030, including abatacept (referencing BMS’ Orencia®) certolizumab (UCB’s Cimzia®), pembrolizumab (MSD’s Keytruda®), nivolumab (BMS’ Opdivo®) and dulaglutide (Eli Lilly’s Trulicity®).
In 2030+, Amneal is planning for 10+ pipeline products to be approved, including biosimilars of dupilumab (referencing Regeneron/Sanofi’s Dupixent®), risankizumab (referencing AbbVie’s Skyrizi®) and guselkumab (referencing Janssen’s Tremfya®).
Amneal presently intends to commercialise the biosimilars itself in the US and India, with a partnership model being employed in the rest of the world.