Samsung Bioepis completes interchangeability study for Humira biosimilar

Samsung Bioepis’ Hadlima, a biosimilar of blockbuster autoimmune diseases drug Humira, met primary endpoints in the interchangeability test, the Incheon-based pharmaceutical company said Wednesday.

Samsung Bioepis' Hadlima, its Humira biosimilar [SAMSUNG BIOEPIS]

Samsung Bioepis’ Hadlima, a biosimilar of blockbuster autoimmune diseases drug Humira, met primary endpoints in the interchangeability test, the Incheon-based pharmaceutical company said Wednesday.

When designated as an interchangeable drug by the U.S. Food and Drug Administration (FDA), the biosimilar can be substituted for its reference product at the pharmacy.

“We have confirmed that the Humira biosimilar achieved its primary endpoint in an interchangeability study, and we plan to proceed with the relevant regulatory approvals,” Samsung Bioepis said in a press release.

Hadlima was first approved by the FDA in 2019 in a low-concentration format, and the high-concentration formulation was approved in August 2022. Hadlima began hitting the shelves in the U.S. market in July, with local sales handled by New Jersey-based Organon.

BY SHIN HA-NEE [shin.hanee@joongang.co.kr]