FDA approves Hadlima, fourth Humira biosimilar
The FDA has approved the fourth biosimilar to adalimumab, adalimumab-bwwd, for all eligible indications of the biologic product, according to a company press release.
Hadlima (adalimumab-bwwd, Samsung Bioepis), a biosimilar to Humira (adalimumab, AbbVie), is a TNF inhibitor intended to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
Hadlima is the fourth biosimilar to Humira to gain FDA approval in the United States, following Hyrimoz (adalimumab-adaz, Sandoz) in 2018, Cyltezo (adalimumab-adbm, Boehringer Ingelheim) in 2017 and Amjevita (adalimumab-atto, Amgen) in 2016. However, to date, none of these biosimilars have been launched in the U.S. market.
“With the approval of Hadlima, we are proud to have three anti-TNF biosimilars approved in the U.S. We believe the U.S. health care 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,” Hee Kyung Kim, senior vice president and head of regulatory affairs at Samsung Bioepis, said in a press release. “We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems can benefit from biosimilars.”
The FDA based its approval on a 52-week randomized, double-blind phase 3 trial comparing the safety and efficacy of Hadlima against the reference product among patients (n = 544) with moderate to severe rheumatoid arthritis who had previously failed to respond to methotrexate.
According to study results, at week 24, the ACR20 response rate was 72.4% in patients who received Hadlima vs. 72.2% in patients who received the reference product. Up to week 52, Hadlima demonstrated therapeutic equivalence in the treatment of these patients, with a comparable safety and immunogenicity profile to the reference biologic.