Celltrion Launches Full-Scale Development of Keytruda Biosimilar, World's Top-Selling Drug

PD-1 Family Immune Checkpoint Inhibitor Market Entry
$25 Billion Revenue in 2023... Surpassing Humira to Claim 'No.1'
By 2030, Celltrion Expected to Lead the 'Third Wave'

Celltrion is set to actively pursue the development of a biosimilar for the blockbuster immuno-oncology drug Keytruda.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

On the 17th, Celltrion announced that on the 14th (local time), it submitted a global Phase 3 clinical trial plan to the U.S. Food and Drug Administration (FDA) for CT-P51, a biosimilar under development for Keytruda. This clinical trial will compare the efficacy and safety of CT-P51 with the original drug in 606 patients with metastatic lung cancer.

Keytruda is a programmed cell death receptor (PD)-1 class immuno-oncology drug developed by MSD. It is a mega blockbuster drug that generated global sales of $25 billion (approximately 34.725 trillion KRW) last year alone. This accounts for nearly 41.6% of MSD’s total sales of $60.1 billion last year. As a single drug, it surpassed Humira, an autoimmune disease treatment with $14 billion in sales, becoming the world’s top-selling drug. In addition to lung cancer, Keytruda has secured indications for 14 types of cancer domestically, including melanoma, head and neck cancer, breast cancer, and cervical cancer, and is still expanding its indications. Its core patent is expected to expire around 2028, prompting companies such as Samsung Bioepis and Chong Kun Dang, as well as Celltrion, to accelerate biosimilar development.

Under the slogan “The Third Wave” aiming for 2030, Celltrion has pledged to complete the development of a total of 22 biosimilar products, identifying PD-1 class anticancer drugs as one of the targets. However, this is the first time the company has publicly disclosed clinical trials for this class of products. Especially since various products, including Bristol-Myers Squibb (BMS)’s Opdivo, are expanding the market, the PD-1 class anticancer drug market is expected to grow to $58 billion (approximately 78 trillion KRW) by next year. If Celltrion succeeds in developing a PD-1 class biosimilar, expectations for the company’s revenue growth are likely to increase further.