Alvotech Sets Sights On Stelara Submission By Close Of 2022
Company In Strong Position To Capitalize On Ustekinumab Opportunity
Tipped to bring in revenues from its proposed Stelara biosimilar of $600m in 2027, Alvotech has confirmed plans for a potentially landmark filing with major regulators by the end of the year.
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Alvotech and Stada have indicated that they could receive an EMA opinion on their AVT04 Stelara biosimilar as early as the second half of 2023, after the agency confirmed acceptance of their ustekinumab filing.
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.