Samsung Bioepis said Thursday that it has settled a patent dispute with AbbVie regarding Imraldi, the company’s biosimilar of AbbVie’s Humira.
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.
Under the accord, Samsung Bioepis will now be available to launch Imraldi in Europe from Oct. 16. For the U.S., if approved, the company will be able to market its drug after June 30, 2023.
The company had previously received marketing authorization from the European Commission (EC) in August last year. In the U.S., the company has not yet received regulatory approval.
“We welcome this agreement which clears the way for Imraldi in approved markets across the world,” said Kim Jay-woo, senior vice president and head of the commercial division at Samsung Bioepis. “The earliest impact of this agreement will likely be seen in Europe, where the drug has already been approved and is expected to become our third TNF inhibitor available in the region.”
Kim went on to say, “We remain dedicated to advancing one of the industry's most reliable biosimilar pipelines, so that more patients and healthcare systems across the world may benefit from biosimilars.”