'34 Trillion Market' Keytruda, Samsung Bioepis Biosimilar Phase 3 Clinical Trial Begins

Samsung Bioepis is accelerating the development of SB27, a biosimilar of the blockbuster immuno-oncology drug Keytruda, selected as its 11th biosimilar pipeline.

Exterior view of Samsung Bioepis building in Songdo, Incheon [Photo by Samsung Bioepis]

Samsung Bioepis announced on the 5th that it has recently initiated Phase 3 clinical trials for SB27. This trial will be conducted by recruiting 616 patients with metastatic non-small cell lung cancer across 14 countries globally, comparing the efficacy, safety, and pharmacokinetics of SB27 with the original drug.

Keytruda is an immuno-oncology drug developed by MSD. It generated global sales of $25 billion (approximately 34 trillion KRW) last year alone, making it a mega blockbuster drug. This figure accounts for nearly 41.6% of MSD’s total sales of $60.1 billion last year. Additionally, it became the world’s top-selling drug by revenue, surpassing Humira, an autoimmune disease treatment with $14 billion in sales. Starting with lung cancer, Keytruda 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.

The initiation of this Phase 3 trial comes just over three months after starting Phase 1 trials in four countries globally in January. To speed up development, Samsung Bioepis adopted an 'overlap' strategy, conducting Phase 1 and Phase 3 trials simultaneously.

MSD's immuno-oncology drug Keytruda

Hong Ilseon, General Manager (Executive Director) of the Product Evaluation (PE) team overseeing Samsung Bioepis’s clinical trials, said, "We are doing our best to develop the Keytruda biosimilar in a timely manner," adding, "We will continue to make efforts to improve patient access to high-cost drugs and reduce the national financial burden."

This content was produced with the assistance of AI translation services.