FDA okays switching Humira with Boehringer's Cyltezo biosimilar

Boehringer Ingelheim announced that the FDA has approved its supplemental filing for Cyltezo (adalimumab-adbm) as the first "interchangeable biosimilar" with AbbVie's Humira (adalimumab). The FDA originally cleared Cyltezo in 2017 for multiple chronic inflammatory diseases and this latest approval designates it as interchangeable across all of these indications, meaning it can now be substituted for Humira without the prescriber having to change the prescription.

Cyltezo becomes the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. In July, the FDA authorised Viatris' biosimilar insulin product Semglee (insulin glargine-yfgn) to be substituted for Sanofi's long-acting insulin analogue Lantus (insulin glargine).

Launch slated for mid 2023

Boehringer Ingelheim noted that Cyltezo is not commercially available in the US at the moment, but that its commercial license will begin in July 2023, following a patent settlement agreement reached with AbbVie a few years ago.

According to Boehringer Ingelheim, the approval for interchangeability was backed by the Phase III VOLTAIRE-X trial, which studied the effects of multiple switches between Humira and Cyltezo. The company said the findings, presented earlier this year at the American Academy of Dermatology (AAD) conference, found "no meaningful clinical differences" in terms of pharmacokinetics, efficacy, immunogenicity and safety between the switching and continuous treatment groups.

There are five other Humira biosimilars approved and lined up for market entry in 2023 as well, with Cyltezo expected to be among the first to enter the market. Launching in June 2023 is Hadlima, a biosimilar developed by Samsung Bioepis and slated for launch in partnership with Merck & Co.'s Organon spinout, although it does not have interchangeable status. The other Humira biosimilars that have FDA approval are expected to launch in later months of 2023.

AbbVie, which is slated to report third-quarter results next week, said in July that Humira had generated sales of $5.1 billion in the second quarter, which was up nearly 5% from the year-ago period.

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