South Korea-based Samsung (SSNLF  ) first made its foray into the US pharma market as Samsung Bioepis in 2017, planning to create high-quality medicines through the development of biosimilars, or medicines that mimic the function of their original natural counterpart.

The entry into the biopharmaceutical market hasn't been without its hurdles. Samsung is currently facing competition from pharma behemoths in the US who already have well-established links with medical institutions, insurers, and healthcare-providers. These companies are using these ties to undercut the company through establishing exclusive contracts with them before Samsung can. They're also offering rebates that Samsung currently cannot because it doesn't have the same scale.

Samsung Bioepis debuted on the US market in 2017 with a rheumatoid-arthritis drug called Remicade, a cheaper alternative to other drugs. Recently, it also partnered with 3SBio in China to expand its presence in mainland China.

"Samsung Bioepis possesses leading biologic development and manufacturing capabilities in the global market, combined with 3SBio's advantageous integrated platform in China, the 2 parties can provide patients in China with safe and affordable biological therapies," Jing Lou, PhD, chairman and chief executive officer of 3SBio, said in a statement. "3SBio looks forward to accelerating the clinical development of SB8 in China, and to broaden 3Bio's product portfolio in the oncology area."

However, Samsung is unable to accumulate such clout in the US: "It's been a much longer journey than we expected," said Christopher Ko.

Aside from cutthroat competition, Samsung has thus far been unable to convince doctors of the quality of their pharmaceuticals, with many medical practitioners skeptical of the cheaper alternatives. This, coupled with the fact that Samsung Bioepis is privately held, has made the level of transparency between the company and potential consumers very low. Even revenue is not reported. The most pressing obstacle that lies between Samsung Bioepis and success in the US pharmaceutical market is that biosimilars face nationwide skepticism for being knock-offs that aren't identical to trusted sources and therefore are considered to be untrustworthy. This stems from US harboring culture of lawsuits and high health standards, which explains the discrepancy between the company's success in the Chinese market relative to the American market.

"We haven't given health-care payers any reason to spend a lot of time thinking about biosimilars yet, though as the number of products goes up, I think those payers will get more interested," Mr. Ko said.

The company is also facing a criminal investigation and potential delisting in South Korea after allegations of accounting fraud that occurred in 2015 ahead of its 2016 IPO.