The FDA Tuesday approved Samsung Bioepis’ Hadlima (adalimumab-bwwd), referencing Humira.
This article has been updated.
The FDA on Tuesday approved Samsung Bioepis’ Hadlima (adalimumab-bwwd), referencing Humira.
Hadlima, a subcutaneous injection, was cleared for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.
"With the approval of Hadlima, we are proud to have three anti-TNF biosimilars approved in the US. We believe the US healthcare system can benefit from biosimilars, which could play a critical role in broadening access to treatment options for patients with autoimmune conditions across the country," said Hee Kyung Kim, senior vice president and head of regulatory affairs, Samsung Bioepis, in a statement. “We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems can benefit from biosimilars.”
A pivotal pharmacokinetic (PK) study of the biosimilar in healthy volunteers was conducted in Germany. This study was a randomized, single-blind, 3-arm, parallel group, single-dose phase 1 study in 189 healthy volunteers who were randomized to receive the biosimilar or the reference. All of the 90% confidence intervals (CIs) for the geometric least squares means ratios of primary PK parameters for the biosimilar and the EU and US reference products fell within the prespecified equivalence margin of 0.8 to 1.25.
The biosimilar was also studied in a phase 3 study in patients with moderate to severe rheumatoid arthritis. In the study, patients who failed to respond adequately to methotraxate were randomized to receive the biosimilar (n = 269) or the reference (n = 273) at a dose of 40 mg every other week. The primary efficacy end point was the response rate based on the American College of Rheumatology 20% improvement criteria (ACR20) at week 24.
The ACR20 response rate at week 24 was equivalent between the 2 arms (72.4% and 72.2%, respectively), and the difference in ACR20 response rate was 0.1% (95% CI, −7.83% to 8.13%) within the prespecified equivalence margin of plus or minus 15%. Both adalimumabs were well tolerated and had comparable safety profiles.
The biosimilar is also approved in the European Union, where it has launched in numerous markets. However, Samsung Bioepis and Biogen, with partner Merck, will not be free to launch the product in the United States until June 30, 2023, under the terms of a patent litigation settlement with Humira’s sponsor, AbbVie.
Hadlima, which is approved as Imraldi in the European Union, joins Amgen’s Amjevita, Boehringer Ingelheim’s Cyltezo, and Sandoz’s Hyrimoz as FDA-approved, but unlaunched, biosimilar adalimumab products.
Earlier in the day Tuesday, the FDA approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan.
1. Shin D, Kim Y, Kim HS, Fuhr R, Kornicke T. A phase 1 pharmacokinetic study comparing SB5, an adalimumab biosimilar, and adalimumab reference product (Huimra) in healthy subjects. Ann Rheum Dis. 2015;74:459-460. ard.bmj.com/content/74/Suppl_2/459.3.info
2. Weinblatt ME, Baranauskaite A, Niebrzydowski J, et al. Phase III Randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate‐to‐severe rheumatoid arthritis. Arthritis Rheumatol. 2018; 70(1):40-48. doi: 10.1002/art.40336.