Alvotech settlement completes the list of Humira challengers

The ninth and final company eyeing the Humira US biosimilar opportunity settled with Abbvie this week. Alvotech’s AVT02 can technically be launched alongside biosimilars from Pfizer and Boehringer Ingelheim on July 1, 2023, although it seems unlikely that FDA approval will arrive in time. The private Icelandic firm, partnered with Teva in the US, claims that its copycat has two advantages, being both interchangeable and available at a high concentration. Boehringer has also won interchangeability, but no one else has a high-concentration product approved yet. This formulation accounts for around 80% of Humira prescriptions, according to Bernstein analysts, who reckon that interchangeability is the more important characteristic. One thing is certain: competition will be fierce once the gates are open, and Amgen will be incredibly motivated to press home its six-month advantage. Evaluate Pharma’s consensus has US Amjevita sales reaching $1bn by 2026. Alvotech, which is listing on Nasdaq via a Spac, will be hoping for fast work from the FDA; last year the agency deferred its approval decision because the pandemic prevented inspections, setting a new goal date for December 2022. Unless this can be beaten, boasts of differentiation might count for little.