Samsung Bioepis begins phase 3 clinical study for its Keytruda biosimilar

Samsung Bioepis, Samsung Group’s biosimilar arm, announced Friday that the company had started a phase 3 clinical study for SB27, a Keytruda biosimilar.

Keytruda is an immuno-oncology drug developed by MSD, a US multinational pharmaceutical company. Indications for the drug include non-small cell lung cancer (NSCLC), melanoma and neck cancer. According to MSD's earnings release, global sales of Keytruda in 2022 were estimated at $20.9 billion.

Samsung Bioepis will recruit 616 patients with non-small cell lung cancer in 14 countries for its clinical trial comparing safety and efficacy of SB27 with Keytruda.

“Samsung Bioepis is making the best efforts to complete the development of its Keytruda biosimilar in a timely manner. The company will continue its effort to increase patients’ accessibility to expensive drugs and contribute to lowering national health care spendings,” said Hong Il-sun, head of the Product Evaluation Team at Samsung Bioepis.

Since January this year, Samsung Bioepis has been conducting a phase 1 clinical study for SB27 in four countries, including South Korea.

Samsung Bioepis’ decision to begin phase 3 clinical study for the biosimilar has been made to accelerate the development process, according to the company.

In the development of biosimilar drugs, it is possible to initiate a phase 3 trial before the completion of phase 1 comparability trials with the use of interim safety data. Generally, they can also skip the phase 2 trial.