'Samsung Bioepis Targets 33 Trillion Market, Starts Clinical Trial for Keytruda Biosimilar'

Samsung Bioepis has selected the blockbuster immuno-oncology drug Keytruda as its 11th biosimilar pipeline and has begun full-scale development.

Samsung Bioepis researchers are engaged in pharmaceutical development activities.
[Photo by Samsung Bioepis]

Samsung Bioepis announced on the 21st that it has initiated the global Phase 1 clinical trial of the Keytruda biosimilar SB27. This trial will compare the pharmacokinetics, efficacy, and safety of SB27 with the original drug Keytruda in 135 lung cancer patients across four countries including Korea and Spain.

Keytruda is an immuno-oncology drug developed by MSD. It is a mega blockbuster drug that generated global sales of $25 billion (approximately 33 trillion KRW) last year alone. This figure accounts for nearly 41.6% of MSD’s total sales of $60.1 billion last year. Additionally, it surpassed Humira, an autoimmune disease treatment with $14 billion in sales, to become the world’s top-selling single drug. Starting with lung cancer, it has secured indications for 13 types of cancer domestically, including melanoma, head and neck cancer, breast cancer, and cervical cancer, and continues to expand its indications. Its core patent is expected to expire around 2028, prompting companies such as Samsung Bioepis, Celltrion, and Chong Kun Dang to accelerate biosimilar development.

Hong Il-seon, Head of Product Evaluation (PE) Team at Samsung Bioepis (Executive Director), said, "Based on the global clinical trial operation know-how we have accumulated so far, we will do our best to complete the clinical trial on schedule," adding, "We will strive to provide patients with more diverse treatment options as soon as possible."