FDA Approves High-Concentration Formulation of Samsung Bioepis’ Humira Biosimilar


The FDA approval of Samsung Bioepis’ high-concentration, citrate-free formulation of Hadlima, a biosimilar referencing Humira (adalimumab), is the first high-concentration adalimumab biosimilar to be approved in the United States.

Hadlima, 1 of 7 FDA-approved biosimilars referencing Humira (adalimumab), now will be offered in a high-concentration, citrate-free (100 mg/mL) version, as the FDA had granted the new formulation regulatory approval.

The low-concentration (50 mg/mL) formulation of Hadlima (adalimumab-bwwd) was originally approved in July 2019, and both formulations will launch in July 2023. Hadlima is also available in the European Union under the name Imraldi.

Until January 2023, Humira will not face any biosimilar competition because biosimilar manufacturers have made settlement agreements with AbbVie, the maker of Humira, to postpone launches. In July 2023, between 5 and 7 adalimumab biosimilars are expected to launch on the US market.

Adalimumab products are used to treat several rheumatic conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis or axial spondyloarthritis, Crohn disease, and ulcerative colitis.

“With this approval, we now have both a low- and high-concentration adalimumab biosimilar approved by the FDA, marking an important step towards expanding treatment options for patients suffering from certain chronic, autoimmune diseases…. By leveraging our development expertise, manufacturing excellence, and supply chain reliability, we will continue our work to ensure health care systems have more affordable treatment options available,” said Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, in a statement.

Currently in the United States, the high-concentration version of Humira represents about 80% of total adalimumab prescriptions. The new formulation of Hadlima is the first high-concentration adalimumab biosimilar to be approved in the United States. Hadlima will be offered to patients in a prefilled syringe or autoinjector.

Hadlima was developed as part of a commercialization agreement between Samsung Bioepis, the manufacturer, and Organon, a spinoff company of Merck that will be in charge of commercialization in the United States. Organon also commercializes 4 other Samsung Bioepis biosimilars in several global markets: infliximab (Renflexis), etanercept (Brenzys, Eticovo), bevacizumab (Aybintio), and trastuzumab (Ontruzant).

“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 US in 2023…. Today, adalimumab is the largest drug expense in the US. We look forward to making our biosimilar available for those that rely on it to help manage their disease,” said Joe Azzinaro, vice president and global commercial lead biosimilars at Organon.

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