Samsung Bioepis and Organon said Wednesday that the U.S. Food and Drug Administration had approved their citrate-free high-concentration (100 mg/mL) formulation of Hadlima (Ingredient: adalimumab-bwwd), a biosimilar of Humira.
The FDA approved the citrate-free high-concentration version of Hadlima based on clinical data from a randomized, single-blind, two-arm, parallel-group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of Hadlima (100 mg/mL vs. 50 mg/mL) in healthy volunteers.
Hadlima will be available in pre-filled syringe and autoinjector options, with the autoinjector specifically designed with the patient in mind, Samsung Bioepis said. According to Samsung Bioepis, the biosimilar received approval from the FDA as a low-concentration (50 mg/mL) formulation in July 2019. More than five million doses have been sold worldwide under different brand names since 2018.
"With this approval, we now have low- and high- concentration adalimumab biosimilars approved by the FDA, marking an important step toward expanding treatment options for patients suffering from certain chronic, autoimmune diseases," Samsung Bioepis Vice President Jung Byoung-in said. "By leveraging our development expertise, manufacturing excellence, and supply chain reliability, we will continue to ensure healthcare systems have more affordable treatment options."
Organon Vice President and Biosimilar Global Commercial Lead Joe Azzinaro also said, "Based on our success commercializing our adalimumab biosimilar in other markets around the world, combined with our established presence in the biosimilar space, we are excited about the opportunity to launch Hadlima in the U.S. in 2023."
Today, adalimumab is the largest drug expense in the U.S., and the company looks forward to making its biosimilar available for those that rely on the drug to control their disease, Azzinaro added.
Hadlima's original drug, Humira, is the most-sold blockbuster drug globally and recorded about 27 trillion won ($20.5 billion) in sales last year. In Korea, the drug posted 91.2 billion won in sales, according to IQVIA data.
Samsung Bioepis plans to commercialize Hadlima in the U.S. through Organon. If approved, the two companies expect to launch it on July 1, 2023, under a licensing agreement with AbbVie, the original developer of Humira.