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Samsung Bioepis gains FDA approval for Humira biosimilar

Samsung Bioepis said Wednesday it has gained the US Food and Drug Administration’s approval for Hadlima, a biosimilar of AbbVie’s blockbuster autoimmune disease treatment Humira.

This is the firm’s fourth biosimilar to get FDA approval, after Renflexis (Infliximab), Ontruzant (Trastuzumab) and Eticovo (Etanercept).

Hadlima (adalimumab-bwwd) is developed by Samsung Bioepis and will be commercialized in the US by Merck from June 2023, according to a settlement with AbbVie. 

(Samsung Bioepis)
(Samsung Bioepis)

AbbVie’s Humira recorded $19.9 billion worldwide sales in 2018, of which sales in the US accounted for 70 percent at $13.6 billion.

Hadlima joins the long list of other adalimumab biosimilars preparing for launch in the US in 2023.

Amgen’s Amjevita (adalimumab-atto) was first approved in September 2016 and will be launched in January 2023. Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) was approved next and will be launched in July 2023. This was followed by approval for Sandoz’s Hyrimoz (adalimumab-adaz) which will be launched in September 2023.

Coherus BioSciences, Pfizer, Mylan, Momenta and Fresenius Kabi also have settlements with AbbVie to launch their Humira biosimilars in late 2023 after getting FDA approval.

Hadlima is currently the number one Humira biosimilar in the European market. It is known as Imraldi in Europe, where it acquired approval in August 2017 and began sales in October 2018 next to competing products from Amgen and Sandoz.

Imraldi notched accumulated sales of $99.7 million as of second quarter this year, becoming the Humira biosimilar with most market share in Europe.

Hadlima has shown indications it improves conditions of those with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcer colitis and plaque psoriasis.

The biosimilar, like the original bio drug, is flagged with a boxed warning by FDA that says its use can lead to an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections and other infections.

By Lim Jeong-yeo (