Abbvie Inc (ABBV)

[DewDiligence]

FDA approves first interchangeable Humira biosimilar—from B-I:

https://www.prnewswire.com/news-releases/fda-approves-cyltezo-the-first-interchangeable-biosimilar-to-humira-301402331.html

B-I’s Humira biosimilar, called Cyltezo, was approved by the FDA in 2017, but only now was granted the interchangeable designation. B-I can launch Cyltezo in Jul 2023, pursuant to a patent settlement with ABBV.

AMGN will have the first Humira-biosimilar launch in the US market, in Jan 2023 (#msg-134970085), but AMGN’s biosimilar is not substitutable for branded Humira by a pharmacist, as B-I’s is.

Several other companies, including PFE, NVS, and Samsung Bioepis, have FDA-approved (but non-interchangeable) Humira biosimilars, so significant price erosion is coming to the US Humira market in 2023.