FDA approves Samsung Bioepis’ Humira biosimilar

South Korea-based Samsung Bioepis has received approval from the US Food and Drug Administration (FDA) for Hadlima, a biosimilar to Abbvie’s Humira (adalimumab) treatment.

Hadlima is a tumour necrosis factor (TNF) blocker designed to treat rheumatoid arthritis, psoriatic arthritis and juvenile idiopathic arthritis. It can also be used to manage Crohn’s disease in adults, ulcerative colitis ankylosing spondylitis and plaque psoriasis.

The FDA authorisation is based on results from a 52-week Phase III study that compared Hadlima to Humira in a total of 544 moderate to severe rheumatoid arthritis patients who did not respond to prior methotrexate (MTX) therapy.

At week 24, the safety profile of the therapeutics was found to be comparable.

In addition, the ACR20 response rate, a rheumatoid arthritis measure, was 72.4% in patients treated with Hadlima compared to 72.2% in the adalimumab reference product (ADL) arm.

After completion of 24 weeks, 254 patients on ADL were re-randomised to continue the reference drug or transition to Hadlima, while 254 subjects receiving Samsung Bioepis drug continued the same therapy.

The efficacy, safety and immunogenicity profiles in all three treatment groups were comparable up to week 52. Also, no treatment-emergent issues or clinically relevant immunogenicity were reported due to switch of treatments.

Samsung Bioepis senior vice-president and Regulatory Affairs head Hee Kyung Kim said: "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."

Aside from in the US, the company’s adalimumab biosimilar holds approvals in more than 30 markets.

Samsung Bioepis launched the biosimilar in the European Union (EU) in October last year, following the expiry of AbbVie’s Humira patent in the region.

In the US, Merck (MSD) will commercialise the biosimilar, which is expected to be available after 30 June 2023 under a licensing agreement with AbbVie.

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