Samsung Bioepis Shortens Clinical Trials as It Seeks a Competitive Edge

Samsung Bioepis is reportedly undertaking shorter clinical trials in order to gain faster biosimilar approvals as the company seeks to compete with rival developers and to realize its first annual profits.

According to The Investor, Samsung has shortened the duration of its clinical trials to 1 year in an effort to report its data more quickly. Additionally, the Korean biosimilar developer has sent its staff around the globe to the locations of its clinical trials—rather than relying on contract research organizations—in order to better control its timetables and speed approvals.

These efforts, says The Investor, are designed to help the 5-year-old Samsung Bioepis to both gain the competitive advantage of a robust pipeline and to turn a profit after posting annual losses throughout its short history. The company is, however, unlikely to become profitable until its drugs find greater uptake in the US and European markets.

Samsung Bioepis, whose infliximab (Renflexis) was approved by the FDA in April of this year, currently has 4 biosimilar candidates in phase 3 development for the US marketplace. Those drugs are etanercept (SB4 Benepali, referenced on Enbrel), adalimumab (SB5 Imraldi, referenced on Humira), trastuzumab (SB3, referenced on Herceptin), and bevacizumab (SB8, referenced on Avastin). By contrast, the company’s chief rival, fellow Korean biosimilar developer Celltrion, has only 1 biosimilar candidate in phase 3 development for the US market: trastuzumab (CT-P6 Herzuma, referenced on Herceptin).

Yet Samsung Bioepis faces other time-consuming roadblocks to its US sales objectives; in May, Janssen Biotech filed a district court lawsuit to prevent the sale of Samsung Bioepis’ FDA-approved infliximab biosimilar in the United States.

However, that lawsuit hinges on Samsung Bioepis’ purported failure to complete the patent information exchange process as laid out in the Biologics Price Competition and Innovation Act (BPCIA), as well as on the company’s early notice of commercial marketing. The suit finds itself on questionable footing after the Supreme Court’s June ruling in Sandoz v Amgen, which determined that there exists no federal remedy for a failure to engage in the “patent dance,” and that biosimilar makers can provide notice of commercial marketing either before or after FDA approval of a biosimilar product.