Amgen’s Stelara Biosimilar Produces Positive Phase III Results
Firm’s ABP 654 Ustekinumab Candidate Is Also Being Lined Up For Interchangeability
Amgen has reported positive preliminary results from a Phase III study for its ABP 654 proposed ustekinumab biosimilar rival to Stelara, for which the firm also intends to pursue an interchangeability designation.
You may also be interested in...
Alvotech and marketing partner Teva have confirmed that their AVT04 proposed ustekinumab biosimilar rival to Stelara has been filed with the US FDA, ahead of a key patent expiry later this year.
With Janssen’s Stelara set to lose its exclusivity in September 2023, the originator is looking to ward off potential biosimilar competition from Amgen by suing the firm for patent infringement in a US district court.
Hikma has signed another partnership agreement to gain Middle East and North Africa commercialization rights to an ustekinumab biosimilar – although not with its US partner, Bio-Thera Solutions.