Samsung Bioepis Co. forged its inaugural partnership with a Japanese company to crack a notoriously challenging biosimilar market, signing an agreement with Nipro Corp. to distribute copycat versions of blockbuster drugs including Johnson & Johnson’s Stelara.
The Korean developer will handle manufacturing and supply while Nipro manages sales under the arrangement announced Monday. Samsung Bioepis, established in 2012, has obtained approvals for 11 blockbuster biosimilar products but has struggled to penetrate Japan’s complex reimbursement landscape without local expertise.
Japan’s biosimilar market, valued at $140 million in 2017, accounted for just 5 percent of the global market excluding the United States, despite the country representing a much larger share of overall pharmaceutical spending. The partnership targets Stelara biosimilars, with the original drug losing patent protection and facing steep competition from multiple generic versions.
Nipro, founded in 1954, operates across medical devices, pharmaceuticals and packaging with trailing twelve month revenue of $4.14 billion. The Osaka-based company brings established relationships with Japanese healthcare providers, though peculiarities in Japan’s co-payment system can make biosimilars more expensive than original drugs for patients in certain cases.
Samsung Bioepis cited Japan’s biosimilar market potential, though regulatory complexities and reimbursement quirks have historically limited adoption compared to other developed markets.
