
High-Concentration Version of Adalimumab Biosimilar Will Be Available in 2023
The FDA approved the first high-concentration adalimumab biosimilar. A low-concentration version of the biosimilar, Hadlima, was already approved. Both versions will launch in July 2023.
Last week, the FDA approved another adalimumab (Humira) biosimilar; however, this is the first high-concentration adalimumab biosimilar. A low-concentration version of Samsung Bioepis’ Hadlima was first approved by the FDA in July 2019.
There are a total of 7 adalimumab biosimilars approved by the FDA, but due to patents on the reference product, the first of these—Amgen’s Amjevita—will not launch until January 2023. The citrate-free, high-concentration formulation of Hadlima will be available in prefilled syringes and autoinjectors.
Both the low- and high-concentration versions of Hadlima will launch July 2023. The biosimilar is already available in the European Union and marketed as Imraldi.
When the reference adalimumab first launched, it was a low-concentration version. The citrate-free, high-concentration version reduces site injection pain. Currently, the high-concentration version of the reference product has the most market share.
“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,” Byoungin Jung, vice president and regulatory affairs team leader, Samsung Bioepis,
The FDA approval is based on date from a randomized, single-blind, 2-arm, parallel group, single-dose study (NCT04514796) comparing the pharmacokinetics, safety, tolerability, and immunogenicity of the 2 formulations.
Data from the study
The full study results were
Having an approved high-concentration version is also important for payers. In
In addition to Hadlima, Celltrion’s Yuflyma and Alvotech’s AVT02 are high-concetration adalimumab biosimilars who have reached agreements with AbbVie, the maker of the reference product, for the biosimilars to come to market in 2023. Neither are approved by the FDA yet, but applications for both have been submitted to the FDA.
Reference
Ahn SS, Lee M, Baek Y, Lee S. A eandomized pharmacokinetic study in healthy male subjects comparing a high-concentration, citrate-free SB5 formulation (40 mg/0.4 ml) and prior SB5 (adalimumab biosimilar). Rheumatol Ther. 2022;9(4):1157-1169. doi:10.1007/s40744-022-00471-8
Newsletter
Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics.