The therapy was also approved for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
A biosimilar is a biologic medication with a high degree of similarity to another already approved biologic medicine in terms of quality, safety, and effectiveness. Biosimilars are usually sold at significantly lower prices.
Developed by Samsung Bioepis, Hadlima is an anti-TNF therapy that reduces inflammation. It targets a protein known as tumor necrosis factor (TNF), which is involved in inflammatory diseases such as rheumatoid arthritis and ankylosing spondylitis.
The therapy will be commercialized in the United States by Merck (known as MSD outside the U.S. and Canada), and will be available in the U.S. after June 30, 2023.
The FDA’s approval was based on results from a randomized, double-blind, Phase 3 clinical trial (NCT02167139), which compared the safety and efficacy of Hadlima to Humira.
The study enrolled 544 patients with moderate to severe rheumatoid arthritis, who failed to respond to methotrexate treatment (often used to treat rheumatoid arthritis). Participants were randomized to receive Hadlima or Humira, delivered at a 40 mg dose injected into the skin.
The efficacy, safety and immunogenicity (the ability of a compound to generate an immune response) of Hadlima was shown to be very similar to Humira.
By week 24, the ACR20 response rate was 72.4% for patients administered Hadlima compared to 72.2% for those treated with Humira. ACR20 indicates the number of patients who showed a 20% or greater improvement in disease activity from baseline (study start) levels.
Furthermore, when patients were swapped from Humira to Hadlima, at 24 weeks, no adverse effects were seen.
Hadlima is Samsung’s third TNF-targeting biosimilar approved in the U.S.
“With the approval of Hadlima, we are proud to have three anti-TNF biosimilars approved in the U.S. We believe the U.S. healthcare system can benefit from biosimilars, as they could play an important role in broadening access to treatment options for patients with autoimmune conditions,” Hee Kyung Kim, senior vice president and head of regulatory affairs at Samsung Bioepis, said in a press release.
Hadlima is approved in more than 30 countries, including 28 in the European Union, Canada, Australia, and Korea.