Samsung Bioepis has begun clinical development of its next flagship pipeline, a biosimilar of Keytruda (pembrolizumab).

Samsung Bioepis said Wednesday that the company had initiated a global phase 1 clinical trial of SB27, a Keytruda biosimilar, and its 11th biosimilar pipeline.

Samsung Bioepis will recruit 135 patients with non-small cell lung cancer (NSCLC) in four countries, including Korea, to compare the pharmacokinetics, efficacy, and safety of SB27 with the original drug.

Keytruda is an immuno-oncology drug developed by MSD, a U.S. multinational pharmaceutical company with indications for melanoma, NSCLC, and head and neck cancer. According to MSD's earnings release, global sales of Keytruda in 2022 were estimated at $20.9 billion (about 27.88 trillion won).

With the entry into phase 1 of SB27, Samsung Bioepis has 11 biosimilar products and pipelines, seven sold in global markets, including Europe, and three for which clinical trials have been completed.

"Based on our global clinical operation know-how, we will do our best to complete the clinical trials on time so that we can provide patients with more treatment options as soon as possible," said Hong Il-sun, head of the Product Evaluation (PE) Team at Samsung Bioepis.