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.

The $17bn Humira opportunity: US biosimilar pipeline
Product Company Status Expected US launch  Interchangeable?
Amjevita  Amgen Marketed Europe & Japan; approved US  Jan 31, 2023 Interchangeability trials ongoing 
Hadlima Organon/Samsung Bioepis  Marketed Europe & RoW; approved US  Jun 30, 2023 No
AVT02 Teva (US)/Stada (EU)/Alvotech (originator)  Approved Europe & Canada; filed US (approval goal Dec 2022) Jul 1, 2023 Yes (if approved) 
Cyltezo Boehringer Ingelheim Approved Europe but withdrawn from sale; approved US  Jul 1, 2023 Yes
Abrilada Pfizer Approved Europe but no launch planned; US approved  Jul 1, 2023 Filed sNDA for interchangeability in Feb 2022
Yusimry Coherus  Approved US  Jul 1, 2023 No
Hulio Viatris/Biocon  Marketed Europe & RoW; approved US  Jul 31, 2023 No
Hyrimoz Sandoz (Novartis) Marketed Europe; approved in US  Sep 30, 2023 No
Idacio Fresenius Kabi Marketed Europe & Canada; US phase 3  Sep 30, 2023 No
Source: Evaluate Pharma & company statements. 

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