The European Commission (EC) has approved Samsung Bioepis’ Imraldi — a biosimilar referencing adalimumab (Humira) — for the treatment of various forms of arthritis, psoriasis and Crohn’s disease as well as, adult and adolescent hidradenitis suppurativa, ulcerative colitis and uveitis.
Approval
Imraldi is the third biosimilar that targets TNF-α from the company to gain approval and follows the positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) that was received in June.
“We are proud to become the industry’s first to obtain European approval for a third TNF inhibitor. This is a testament to our agile biologics development platform, which has allowed us to develop approved biosimilars in less time at lower cost,” said Christopher Hansung Ko, president & CEO of Samsung Bioepis. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients and healthcare systems across Europe will benefit from biosimilars.”
This approval applies to all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Biogen will commercialise Imraldi in the EU and EEA member states.