Samsung Bioepis – a joint venture between Samsung BioLogics and Biogen – announced the launch of Imraldi two days after the expiry of AbbVie’s Humira (adalimumab) patent protection in Europe.
Biogen, which will market Imraldi on behalf of Samsung Bioepis, is the third company to launch an adalimumab biosimilar in Europe this week.
On Tuesday, Novartis subsidiary Sandoz and Amgen also announced their Humira biosimilars – marketed as Hyrimoz and Amgevita respectively – are now available in Europe.
Imraldi has been approved for all indications as per its reference product, including for the treatment of rheumatoid arthritis, psoriasis, and Crohn’s disease.
Anti-TNF focus
The approval marks Samsung Bioepis’ third in the European anti-tumour necrosis factor (TNF) market, following biosimilar launches of etanercept (Enbrel) and infliximab (Remicade) in 2016.
“We look forward to increasing patient access to this important medicine by leveraging our industry-leading position in the European anti-TNF market,” wrote head of Biogen’s biosimilars unit, Ian Henshaw, in a statement.
“We hope Imraldi will play an important role widening choice and increasing competition in one of the most high-value areas of the biopharmaceuticals market,” added Samsung Bioepis COO, Sang-Jin Pak.
US agreements
In the US, patent protection is preventing entry of Humira biosimilars to the market. AbbVie is expected to continue to benefit from the blockbuster’s sales for another five years – Humira brought in $18.43bn (€15.76bn) in sales last year.
Samsung Bioepis, Amgen and Mylan are among the companies to have developed Humira biosimilars for the US, awaiting market entry. Separate patent licensing agreements signed between AbbVie and these drugmakers will see the first Humira biosimilars enter the US market in 2023.
