Last week, the FDA approved another adalimumab biosimilar (Humira); however, this is the first high-strength adalimumab biosimilar. A low-strength version of Hadlima from Samsung Bioepis was first approved by the FDA in July 2019.
There are a total of 7 FDA-approved adalimumab biosimilars, but due to patents on the reference product, the first of these, Amjevita from Amgen, will not be launched until January 2023. The citrate-free formulation and high-strength Hadlima will be available in pre-filled syringes and auto-injectors.
Low- and high-strength versions of Hadlima will be launched in July 2023. The biosimilar is already available in the European Union and marketed as Imraldi.
When the adalimumab reference was first launched, it was a low-strength version. The citrate-free, high-concentration version reduces pain at the injection site. Currently, the high concentration version of the reference product has the largest market share.
“With this approval, we now have an FDA-cleared low- and high-strength adalimumab biosimilar, marking an important step toward expanding treatment options for patients with certain chronic autoimmune diseases,” said said Byoungin Jung, Vice President and Head of Regulatory Affairs Team. , Samsung Bioépis, said in a press release. “Leveraging our development expertise, manufacturing excellence and supply chain reliability, we will continue our work to ensure healthcare systems have more affordable treatment options” , she added.
FDA approval is based on the date of a randomized, single-blind, 2-group, parallel-group, single-dose study (NCT04514796) comparing the pharmacokinetics, safety, tolerability, and immunogenicity of the 2 formulations.
Study data presented at EULAR 2022, the annual congress of the European Alliance of Rheumatology Associations, demonstrated pharmacokinetic equivalence of low-strength Hadlima and the high-strength version in healthy subjects male. There were similar treatment-related adverse events between the low and high concentration versions. While the incidence and severity of injection site reactions were low in both groups, the incidence was lower in the group receiving the high concentration formulation.
The full results of the study have been published on July 1 in Rheumatology and Therapy.1 “Reducing injection site reactions and pain may have a positive effect on treatment adherence in patients with chronic conditions that require repeat doses,” the researchers explained.
In a presentation at Asembia’s 2022 Specialty Pharmacy Summit in May 2022, Sonia Oskouei, PharmD, Vice President of Biosimilars at Cardinal Health, explained that European colleagues who used adalimumab biosimilars anecdotally reported that patients prefer the citrate-free version because it doesn’t hurt.
Having an approved high concentration version is also important for payers. In another session at Asembia, Jeffrey Casberg, MS, RPh, vice president of pharmacy at IPD Analytics, LLC, explained that since the high-strength version has about 85% of the market share, payers won’t have to worry about moving patients from the new formulation to the old formula. Pharmacies and payers won’t have to worry about patient conversion, and having biosimilars for both formulations “will make that adoption much more robust,” he said during his presentation.
In addition to Hadlima, Celltrion’s Yuflyma and Alvotech’s AVT02 are high-strength adalimumab biosimilars that have entered into agreements with AbbVie, the manufacturer of the reference product, to bring the biosimilars to market in 2023. None are yet approved by the FDA, but applications for both have been submitted to the FDA.
Ahn SS, Lee M, Baek Y, Lee S. A randomized pharmacokinetic study in healthy male subjects comparing a high-strength, citrate-free SB5 formulation (40 mg/0.4 mL) and an earlier SB5 (biosimilar adalimumab) . Rheumatol Ther. 2022;9(4):1157-1169. doi:10.1007/s40744-022-00471-8