On 21 February, the US biotech company AbbVie and the Japanese pharmaceutical company Eisai announced they had received approval for an additional indication of Humira (adalimumab) in Japan.

The approval means Humira is the first biological treatment indicated for hidradenitis suppurativa (HS) in Japan.

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Treatment for hidradenitis suppurativa

Humira, the tumour necrosis factor (TNF) inhibitor, is now approved for 11 indications in Japan. GlobalData believes that this will strengthen AbbVie’s profits even though there is increasing competition from Humira biosimilars.

HS is a chronic inflammatory skin condition that is characterised by the development of abscesses and scaring on the skin. The abscesses develop in hair follicle sweat glands. There are limited biological therapies for HS, and currently, Humira is the only approved biologic for HS in the US and European Union (EU).

Humira: Phase II clinical trial

The approval of Humira in Japan for HS is based on data from a Japanese Phase III clinical study and overseas trials. In these trials, the efficacy and safety of Humira were evaluated in patients with moderate to severe HS. In the Japanese clinical trial, 13 out of 15 (87%) patients who received Humira reached their primary endpoint of hidradenitis suppurativa clinical response (HiSCR) at Week 12 of treatment.

Furthermore, in the same trial, 6 out of 15 patients had adverse reactions (ADRs) at 24 weeks of treatment. The ADRs observed in two or more patients were nasopharyngitis and cellulitis, and other ADRs observed in one patient each included dental caries, erythrasma, folliculitis, lymphocyte count increase, erythema, pruritus, and skin exfoliation.

Biosimilar competition and global sales

The approval of Humira for HS in Japan makes it the first-to-market biologic in this indication. 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, AbbVie faces an imminent threat from increasing shares of biosimilar adalimumab, which launched in the EU in 2018.

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, AbbVie reported that Humira generated global sales of $19.9 billion.

This was an 8.2% increase compared to 2017 revenues. GlobalData anticipates that sales of Humira will continue to increase in 2019 despite direct competition from its biosimilar and that the latest approval for HS in Japan will bolster AbbVie’s profits further.