Samsung Bioepis: From biosimilars to novel biologics

Following success with several biosimilars, bringing a novel biologic into the clinic is the “next logical step” in becoming a fully integrated biopharma firm, says Samsung Bioepis.

Almost a year to the date it announced a co-development agreement, Samsung Bioepis and Takeda Pharmaceuticals are preparing to begin a Phase I trial for its lead candidate, SB26, also known as TAK-671.

The news signals the latest stage in the development of Samsung Bioepis – a joint venture between South Korean contract development and manufacturing organization (CDMO) Samsung BioLogics and US biotech Biogen – which, until now, has been most associated with its growing biosimilar portfolio.

“Our decision to enter the biopharmaceutical industry through biosimilars had a lot to do with timing,” Bioepis spokesperson Mingi Hyun told BioProcess Insider.

“With biosimilars, we have been addressing the unmet needs of patients who could not afford or access effective treatment. With novel biologics, we will look to address the unmet needs of patients without viable treatment.” – Samsung Bioepis.

“We were established in 2012. At the time, we quickly realized the value biosimilars could bring to patients over the coming decades, which was increased access to high-quality medicines. Doing so would enable many patients who were previously denied access to finally receive treatment and enjoy higher quality of life, and this was something we could not ignore.”

At the time biosimilars were still new to many in the industry, he continued. “We had the confidence that our development platform and scientists could capitalize on the level playing field, thereby allowing us to compete from the start and positively impact patients’ lives sooner rather than later.”

And so far, Samsung Bioepis’ strategy has paid off. The firm has seen five biosimilars approved in several markets, including a version of J&J’s Remicade (infliximab), Renflexis, approved and launched in the US.

Tackling cost overruns and time delays

Development of novel biologics “is the next logical step” for Samsung Bioepis and has been a goal since day one.

“We entered the biopharmaceutical industry with a strong determination to transform and enhance the way therapies are brought to patients from conception and development through regulatory approval. This means replacing legacy processes with new and innovative ones, as evidenced in what we’ve done so far with biosimilars,” Hyun told us.

“With novel biologics, we will look to bring medicines to treat unmet diseases by breaking down two major hurdles facing biologics development – cost overruns and time delays – a combination of which can not only delay availability of treatment options but can also lead to the termination of drug development programs.”

However, Samsung Bioepis is not looking to make a ‘sudden leap,’ Hyun stressed, but rather take a measured, step-by-step approach to gradually develop and integrate a complete set of capabilities.

“In 10 years’ time, we will have amassed end-to-end capabilities that will allow us to undertake all phases of novel biologics development.”

Partnering

Similar to its biosimilar programs, Samsung Bioepis looks to risk-sharing partnerships to drive development of novel.

“Takeda’s deep heritage in drug development, as well as their extensive knowledge and expertise in drug development, make the company an ideal partner for us,” we were told. TAK-671 is intended to treat severe acute pancreatitis.

And looking forward, Hyun confirmed Samsung Bioepis will be searching for more partnerships though further details have not been divulged.

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