Samsung Bioepis, the biosimilar division of Samsung Group, announced on Monday that it has entered into a commercialization agreement with Nipro, a pharmaceutical and medical device company based in Japan, to penetrate the Japanese market.
The agreement encompasses the licensing, development, and commercialization of several biosimilars, including SB17, which is a biosimilar that references Stelara (ustekinumab) and is utilized for the treatment of autoimmune disorders. This represents the company's inaugural partnership with a pharmaceutical firm in Japan. According to the terms of the agreement, Samsung Bioepis will be responsible for development, manufacturing, and supply, while Nipro will handle sales and distribution within 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.”
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SB17 is a biosimilar to Janssen's Stelara, which is utilized for the treatment of inflammatory conditions such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Earlier this year, Samsung Bioepis introduced its own biosimilar of Stelara, named Pyzchiva, in the United States, which has led to heightened market competition following the expiration of Stelara's US patent in 2023.
After obtaining approval in Europe last year, Pyzchiva achieved a 43 percent market share, establishing itself as a prominent product within the region's biosimilar market. Established in 2012, Samsung Bioepis has successfully secured approval for 11 major biosimilar products and reported revenue of 1.54 trillion won ($1.13 billion) in 2024.
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