Samsung Bioepis has struck a US settlement with Johnson & Johnson that will allow partner Sandoz to launch the pair’s SB17 ustekinumab biosimilar to Stelara in early 2025, assuming FDA approval.

Office of Inspector General analysis could add momentum to reforms of the rebating system.

As Samsung Bioepis seeks a US interchangeability designation for its Organon-partnered Hadlima adalimumab biosimilar, the firm’s regulatory affairs chief Byoungin Jung talks to Generics Bulletin about the significance of interchangeability for US biosimilars – and the firm’s support for legislative efforts to have all US approved biosimilars automatically designated as interchangeable.

Office of Inspector General analysis could add momentum to reforms of the rebating system.