Celltrion's CT-P51 biosimilar to Keytruda receives FDA nod for phase 3 study

Celltrion said Monday that it has received approval from the U.S. Food and Drug Administration (FDA) for the investigational new drug (IND) application for a phase 3 clinical trial of CT-P51, its biosimilar to Keytruda (pembrolizumab).

With this IND approval,  Celltrion plans to initiate a global phase 3 clinical trial involving 606 patients with metastatic non-small cell lung cancer (NSCLC). The trial aims to demonstrate that CT-P51 is as effective as Keytruda, the original drug.

Keytruda, a PD-L1 inhibitor, is an immunotherapy treatment approved for a wide range of cancers, including NSCLC, gastric cancer, and head and neck cancer. It has more than 30 approved indications across various cancer types and stages. 

Merck reported a 32 trillion won ($25 billion) sales haul for Keytruda last year, making it the top-selling pharmaceutical globally, according to industry sources. A Celltrion official said the company is committed to "advancing CT-P51’s development without delay” as it prepares to capture a portion of Keytruda's global market.

Keytruda's substance patents are scheduled to expire in November 2029 in the U.S. and in January 2031 in Europe.

As CT-P51, an immunotherapy treatment, enters the global phase 3 clinical trial stage, Celltrion is expanding its oncology portfolio beyond targeted therapies. While targeted therapies selectively attack specific parts of cancer cells, immunotherapy treatments leverage the body's immune system to eliminate cancer cells.

Previously, Celltrion launched three targeted therapies—Herzuma (trastuzumab) for breast and gastric cancers, Vegzelma (bevacizumab) for metastatic colorectal cancer, and Truxima (rituximab) for hematologic cancers—and has been steadily increasing its market share across Europe, the U.S., and Asia. The successful development of CT-P51 is expected to strengthen Celltrion's oncology portfolio further, the company said. 

Beyond oncology, Celltrion has been expanding its pipeline by securing approvals for new products across various therapeutic areas, including autoimmune diseases, bone disorders, and ophthalmic conditions, while also advancing several phase 3 clinical trials.

For example, Omlyclo (omalizumab), a treatment for allergic asthma, received approvals in Europe and Korea in May and June, respectively, solidifying its position as a first mover in the market, without competitors at the time of approval. The drug was also approved in the U.K. last month. Additionally, Eydenzelt (aflibercept) for wet macular degeneration, and Steqeyma (ustekinumab) for plaque psoriasis, received product approvals in Korea in May and June, respectively.

Celltrion said that it is continuing to expand its market presence in autoimmune disease treatments by “focusing on strengthening its portfolio across various therapeutic areas," with the goal of securing approval for 11 new products by 2025 to drive future growth.

The company recently submitted a global phase 3 clinical trial application to the FDA for Zympentra (infliximab)'s rheumatoid arthritis indication and for the development of CT-P55 (secukinumab), a biosimilar to Novartis’ psoriasis treatment Cosentyx.