Samsung Bioepis Co. Ltd. reports that the U.S. FDA has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
Apparently Samsung Bioepis has become the first company to receive FDA approvals for biosimilars referencing all three first-generation anti-TNF medicines.
What is HADLIMA?
HADLIMA is Samsung Bioepis’ third anti-TNF biosimilar approved for marketing in the United States. HADLIMA is also Samsung Bioepis’ fourth biosimilar approved in the U.S. following the approvals of RENFLEXIX™(infliximab-abda) in April 2017, ONTRUZANT™ (trastuzumab-dttb) in January 2019, and ETICOVO™(etanercept-ykro) in April 2019.
Developed by Samsung Bioepis (a joint venture of Samsung BioLogics and Biogen), the treatment will be commercialized by Merck in the United States or “MSD” outside of the U.S. and Canada. HADLIMA will launch in the U.S. after June 30, 2023 as agreed upon in the licensing agreement executed with AbbVie Inc. It should be noted that AbbVie has 100% protected the U.S. market for HUMIRA with a ingenious, and many argue unfair, patent thicket.
Adalimumab biosimilar has been approved for marketing in over 30 countries including 28 EU member states, Canada, Australia, and Korea.
The FDA made its decision based on the data generated 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).
During week 24, the ACR20 response rate was 72.4% in the HADLIMA group versus 72.2% in the ADL group. In regard to safety, the profile of ADL to HADLIMA was comparable up to week 24 week. By week 24, the sponsor re-randomized 254 patients receiving ADL in a 1:1 ratio to continue on ADL or transition to HADLIMA, and 254 patients receiving HADLIMA continued to receive HADLIMA. By week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. The sponsor reports no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating patients between treatments. Follow the link to the press release below to learn more about important safety information.
Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company developing drugs and therapies available for everyone. The company continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, and ophthalmology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen.