The European Commission (EC) has granted marketing authorization for Samsung Bioepis’s autoimmune disease treatment Imraldi, an adalimumab biosimilar (Original product: Humira), the company said Friday.
Humira is one of the world’s most purchased biomedicine with an estimated 18 trillion won ($15 billion) in sales.
It has applications for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, and uveitis.
EC’s authorization comes only two months after Imraldi received positive marks from the European Medicines Agency (EMA) in June.
With the approval of Imraldi, Samsung Bioepis 삼성바이오에피스 has become the first company that has won sales approvals for the three best-selling anti-TNF biosimilars – Humira, Enbrel, and Remicade -- in Europe.
The company has been marketing Benepali (original product: Enbrel) and Flixabi (original product: Remicade), through their European partner Biogen, since 2016.
“The approval for marketing shows Europe’s recognition of Samsung Bioepis’ research and development (R&D) ability,” said Ko Han-sung 고한승, CEO and President of Samsung Bioepis. “It is also significant that the sales of Imraldi with the already sold Benepali and Flixabi will improve patients’ access to these therapies.”
Samsung Bioepis, a unit of the Samsung Group, was founded as a joint venture between Samsung Biologics and Biogen in 2012. The company is collaborating with Merck, a global Pharmaceutical company, also known as MSD in Korea.
The company’s Herceptin biosimilar is also under review for marketing authorization by the EMA.
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