Biosimilar Developer Samsung Bioepis to Collaborate With Takeda on Novel Biologics

Biosimilar developer Samsung Bioepis announced today that it has signed a collaborative agreement with Takeda to co-develop multiple novel biologic drugs that will target currently unmet needs. The companies’ first project, which they will begin developing immediately, is TAK-671, a prospective treatment for severe acute pancreatitis.

The agreement marks the first foray into novel biologics for Incheon-based Samsung Bioepis; the company has thus far focused entirely on developing biosimilar treatments. Christopher Hansung Ko, president and CEO of Samsung Bioepis, called the agreement a new chapter in the company’s history, and said that “[5] years ago, we entered the biopharmaceutical industry with a strong determination to transform the way therapies are brought to patients by replacing legacy processes with new and innovative ones. Together with Takeda, we look forward to realizing this goal vision by accelerating the development of effective therapies for patients who are currently without a viable treatment option.”

Takeda’s head of the center for external innovation, Daniel Curran, MD, said that it looked forward to the companies’ collaboration and its ability to fuse “our unique capabilities in development and manufacturing along with fresh and innovative clinical approaches.”

BioPharma Dive suggests that Samsung Bioepis’ move to diversify its pipeline could provide the company with a cushion as it waits to reap the rewards of its investments in the biosimilar space. Samsung Bioepis has invested approximately $1.3 billion in biosimilar research and development since it was founded in 2012.

So far, the company has earned $250 million in sales for its etanercept biosimilar, marketed as Benepali, since it launched in the European Union (EU). The company has also gained EU and US approval for its biosimilar infliximab (Renflexis), which launched in the US market in July 2017. It is also awaiting European Medicines Agency decisions on its adalimumab and trastuzumab biosimilars. In the United States, the company is looking ahead to final FDA approval of its follow-on insulin glargine, developed in partnership with Merck, following conclusion of a litigation over a patent dispute with Lantus’ sponsor, Sanofi.

Despite a delay in seeing returns on its substantial investments, Samsung Bioepis does not show signs of backing away from its biosimilar development; the company is currently in phase 3 clinical trials with its SB8, a proposed bevacizumab biosimilar.