AbbVie and Eisai announced recently that Humira, a fully human anti-TNF-α monoclonal antibody, has received additional approval for the treatment of hidradenitis suppurativa (HS) in Japan. This will strengthen AbbVie’s profits even though there is increasing competition from Humira biosimilars, according to GlobalData, a leading data and analytics company.
The approval of this additional indication is based on the data from a Japanese Phase III study and overseas clinical trials. In these trials, the efficacy and safety of Humira were evaluated in patients with moderate to severe HS.
Currently, there are limited biological therapies for HS, a chronic inflammatory skin condition that is characterized by the development of abscesses and scaring on the skin. At present, Humira is the only approved biologic for HS in the US and EU. With the additional approval, it becomes the first-to-market biological treatment indicated for HS in Japan and is now approved for 11 indications in Japan.
Vikesh Devlia, PhD, Pharma Analyst at GlobalData, comments: “AbbVie has continued with its trend of being the first company to launch Humira for HS in a market, as it did in the US and EU. However, the company faces an imminent threat from increasing shares of bio-similar adalimumab, which launched in the EU in 2018.”
Nevertheless, the approval of Humira in Japan shows that AbbVie strives to increase its global market share while also increasing the number of indications it can treat with this biologic. In 2018, the company reported that Humira generated global sales of $19.9bn, an 8.2% increase compared to 2017.
Devlia concludes: “GlobalData anticipates the sales of Humira to continue to increase in 2019 despite direct competition from biosimilars and the latest approval for HS in Japan will bolster AbbVie’s profits further.”