FDA Approves Samsung Bioepis’ HADLIMA

Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA^{® i} (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Please see below the full indications and Boxed Warning for HADLIMA™.

HADLIMA™ is Samsung Bioepis’ third anti-TNF biosimilar approved for marketing in the United States (US). HADLIMA™ is also Samsung Bioepis’ fourth biosimilar approved in the US, following the approvals for RENFLEXIS™ (infliximab-abda) in April 2017, ONTRUZANT™ (trastuzumab-dttb) in January 2019 and ETICOVO™ (etanercept-ykro) in April 2019.

HADLIMA™ was developed by Samsung Bioepis, and will be commercialized in the US by Merck, also known as MSD outside of the US and Canada. HADLIMA™ is expected to launch in the US after June 30, 2023, in accordance with a licensing agreement signed with AbbVie Inc.

“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, 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.”

In addition to the US, Samsung Bioepis’ adalimumab biosimilar has been approved for marketing in over 30 countries, including 28 European Union (EU) member states, Canada, Australia and Korea.

The FDA approval was based on data derived from a randomized, double-blind 52-week Phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomized to receive either HADLIMA™ or the adalimumab reference product (ADL). At Week 24, the ACR20 response rate was 72.4% in the HADLIMA™ group versus 72.2% in the ADL group. The safety profile of HADLIMA™ was comparable to ADL up to Week 24. At Week 24, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or transition to HADLIMA™, and 254 patients receiving HADLIMA™ continued to receive HADLIMA™. Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments. – Bio Space