South Korea–based Celltrion Healthcare announced on April 27 that it has completed its negotiations with AbbVie and that it expects to launch its biosimilar at the same time as the rest of the field—in July 2023. It was the last remaining Abbvie licensing deal to be completed for the Humira® biosimilars.
Celltrion’s biosimilar, CT-P17, is currently undergoing review by the FDA. Celltrion submitted its 351(k) application in November 2020, which should result in an FDA decision before the end of this year. The drug is sold under the brand name Yuflyma® in Canada, the EU, and in Asia. This adalimumab biosimilar is a high-concentration, citrate-free agent.
The licensing agreement signed by Celltrion is not expected to vary substantially from the arrangements inked by the other eight adalimumab biosimilar makers vying for US marketshare in 2023. That is, royalties will be paid to AbbVie on sales of their individual biosimilars, while all ongoing patent litigation is dropped by the maker of Humira. As many as seven biosimilar manufacturers intend to launch their products in July 2023. Amgen will launch in January, with a 6-month lead on the rest, and Samsung Bioepis will launch in June 2023.
It seems that Celltrion will not seek a marketing partner for the new product; it markets this drug in Canada with internal personnel. Currently, Teva is the company’s marketing partner for its approved oncology biosimilars Truxima® and Herzuma® (and Teva is already contracted to market Alvotech’s adalimumab biosimilar entry). It is also engaged with Pfizer to market its infliximab biosimilar Inflectra® (and Pfizer is preparing to launch its own adalimumab biosimilar in July 2023 called Abrilada®). In the adalimumab category, it looks like all the potential biosimilar marketing partners have already been asked to the dance.