Anti-TNF Biosimilar Hadlima Receives FDA Approval

The Food and Drug Administration (FDA) has approved Hadlima (adalimumab-bwwd; Samsung Bioepis), a biosimilar to Humira (adalimumab; Abbvie).

Hadlima, a tumor necrosis factor (TNF) blocker, is indicated for:

• Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA; may be used alone or with methotrexate (MTX) or DMARDs.
• Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients ≥4 years old; may be used alone or with MTX.
• Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with PsA; may be used alone or with non-biologic DMARDs.
• Ankylosing spondylitis (AS): reducing signs/symptoms in patients with active AS.
• Adult Crohn disease (CD): reducing signs/symptoms, inducing and maintaining clinical remission for moderately to severely active CD in patients with inadequate response to conventional therapy; reducing signs/symptoms, inducing clinical remission in patients who have also lost response to or are intolerant to infliximab.
• Ulcerative colitis (UC): inducing and sustaining clinical remission for moderately to severely active UC in adult patients with inadequate response to immunosuppressants (corticosteroids, azathioprine, or 6-MP).
• Plaque psoriasis (PsO): treating adult patients with moderate to severe chronic PsO who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

The approval was based on data from a double-blind, 52-week phase 3 study that evaluated the efficacy and safety of Hadlima in 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Patients were randomized to receive either Hadlima or the adalimumab reference product.

Results showed that at Week 24, the ACR20 response rate was 72.4% for patients treated with Hadlima compared with 72.2% for the reference product; the safety profile was also found to be comparable. Additionally, patients were randomized at Week 24 in a 1:1 ratio to either continue on the reference product or transition to Hadlima for the remainder of the study. At Week 52, the efficacy, safety and immunogenicity profiles remained comparable with no treatment emergent issues from transitioning patients between treatments.

Like the reference product, Hadlima carries a Boxed Warning for serious infections and malignancy.

The expected launch date for Hadlima in the US will be after June 30, 2023.

“We believe the US healthcare system can benefit from biosimilars, as they could play an important role in broadening access to treatment options for patients with autoimmune conditions,” said Hee Kyung Kim, Senior Vice President and Head of Regulatory Affairs, Samsung Bioepis. “We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems can benefit from biosimilars.”

Hadlima will be available as 40mg/0.8mL preservative-free solution in a single-dose prefilled syringe or PushTouch Autoinjector for subcutaneous injection.

For more information visit samsungbioepis.com.