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Korea Made Humira Biosimilar Begins Sales in Australia, Marks its Presence in Third Overseas Market
After launching in Canada in February, Korea’s Samsung Bioepis began selling HUMIRA’s biosimilar HADLIMA (adalimumab) in Australia in partnership with MSD Australia (Merck & Co. in the U.S. and Canada).
What is Adalimumab?
Adalimumab is an anti-TNF biosimilar of AbbVie’s hot-selling drug Humira that is approved for numerous indications. They include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, and plaque psoriasis.
Adalimumab is Samsung Bioepis’s third anti-TNF biosimilar approved in the US, following BRENZYS (etanercept) and RENFLEXIS (infliximab) in 2016 and 2017 respectively. Meanwhile, adalimumab is also Samsung Bioepis’s fourth biosimilar overall to be approved in the US after RENFLEXIS, ONTRUZANT (trastuzumab-dttb), and ETICOVO (etanercept-ykro).
Collaboration with Biogen and Merck & Co.
Before entering the market in Australia, adalimumab was firstly sold under the name of IMRALDI in Europe in 2018 in partnership with Biogen.
It was then launched in Canada working with Merck Canada in February 2021. This came after Samsung Bioepis’ agreement with Merck & Co. in 2013 where Samsung Bioepis will be in charge of clinical trials, manufacturing, and regulatory registration of the drug, and Merck & Co. will handle the commercialization and approval in partnered countries.
Clinical Trial Data Leading to FDA Approval
Adalimumab is currently approved in 6 countries: Australia, Canada, Europe, Switzerland, the US, and Korea. The FDA approval is a result of positive data from a Phase 3 clinical trial conducted in 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy.
After randomly receiving adalimumab or the reference product in Week 24, the drug arm expressed a similar response rate with the reference group (72.4% vs. 72.2%). The efficacy, safety, and immunogenicity profiles of the drug were comparable to that of the reference.
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