Samsung Bioepis, the biosimilar unit of Samsung Group, announced Monday that it has signed a commercialization agreement with Japan-based pharmaceutical and medical device company Nipro to enter the Japanese market.

The deal covers the licensing, development and commercialization of multiple biosimilars, including SB17, a biosimilar referencing Stelara (ustekinumab), used to treat autoimmune conditions.

This marks the company's first partnership with a Japanese pharmaceutical company. Under the agreement, Samsung Bioepis will oversee development, manufacturing and supply, while Nipro will manage sales and distribution in Japan.

“The partnership is a major milestone for our entry into Japan,” said Samsung Bioepis CEO Kim Kyung-ah. “We aim to enhance patient access to high-quality biopharmaceuticals through close collaboration with local partners.”

SB17 is a biosimilar to Janssen's Stelara, which treats inflammatory diseases such as psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Samsung Bioepis launched its proprietary Stelara biosimilar, Pyzchiva, in the US earlier this year, followed by an increased market competition after Stelara's US patent expiry in 2023.

After receiving approval in Europe last year, Pyzchiva went on to secure a 43 percent market share, emerging as a leading product in the region’s biosimilar market.

Founded in 2012, Samsung Bioepis has gained approval for 11 blockbuster biosimilar products and posted 1.54 trillion won ($1.13 billion) in revenue in 2024.

Meanwhile, Samsung Bioepis is scheduled to separate from its parent company, Samsung Biologics, in October to operate as a new holding company, a strategic move aimed at easing client concerns over potential conflicts of interest between Samsung Biologics' contract development and manufacturing business and Samsung Bioepis’ biosimilar unit.

By Park Soo-bin (spark@heraldcorp.com)