As Organon recently reported biosimilars sales that slid slightly in the third quarter – with ‘lumpy’ factors such as tender timings obscuring a performance that is expected to deliver double-digit growth overall this year (see sidebar) – CEO Kevin Ali took the opportunity of the Q3 earnings call to talk up the firm’s prospects for its launch of Hadlima (adalimumab-bwwd) in the US next year.
The Samsung Bioepis-developed Humira biosimilar was approved in a 50mg/ml formulation in mid-2019 (Also see "Samsung Bioepis Gets US Adalimumab Nod" - Generics Bulletin, 24 July, 2019.), with the product recently achieving a milestone by being further approved by the US Food and Drug Administration in a 100mg/ml presentation