Celltrion Advances Darzalex Biosimilar CT-P44 with FDA and EMA Phase 3 Trial Approvals
Key Insights
Celltrion has received FDA approval for a Phase 3 clinical trial of CT-P44 (search), a biosimilar to Janssen's Darzalex, targeting relapsed or refractory multiple myeloma (search).
The global Phase 3 trial will enroll 486 patients to compare the pharmacokinetics, efficacy, and safety of CT-P44 (search) with Darzalex.
Darzalex, a monoclonal antibody targeting the CD38 (search) protein, had global sales of $9.74 billion in 2023, with patents expiring in the U.S. in 2029 and Europe in 2031.
Celltrion is moving forward with its Darzalex (daratumumab) biosimilar, CT-P44 (search), after receiving approval from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to initiate a global Phase 3 clinical trial. This trial will evaluate the efficacy and safety of CT-P44 in comparison to the original Darzalex for the treatment of relapsed or refractory multiple myeloma (search).
Phase 3 Trial Details
The Phase 3 trial is set to enroll 486 patients globally who have relapsed or are refractory to previous multiple myeloma (search) treatments. The study aims to demonstrate that CT-P44 (search) is similar to Darzalex in terms of pharmacokinetics, efficacy, and safety. This is a crucial step in bringing a more affordable treatment option to patients with multiple myeloma, a cancer affecting plasma cells in the bone marrow.
Darzalex Market and Patent Expiry
Darzalex, developed by Janssen, is a monoclonal antibody that targets the CD38 (search) protein found on the surface of multiple myeloma (search) cells, inhibiting their growth. In 2023, Darzalex generated approximately $9.74 billion in global revenue, underscoring the significant need for effective treatments for this condition. However, its substance patent is set to expire in the U.S. in 2029 and in Europe in 2031, paving the way for biosimilars like CT-P44 (search) to enter the market.
Celltrion's Oncology Pipeline
CT-P44 (search) is a key component of Celltrion's expanding oncology biosimilar portfolio. The company already has a strong presence in the market with biosimilars such as Truxima (rituximab), Herzuma (trastuzumab), and Vegzelma (bevacizumab). Celltrion is also developing next-generation cancer treatments, including antibody-drug conjugates (ADCs) like CT-P70 and CT-P71, which target solid tumors such as non-small cell lung cancer (search) (NSCLC) and bladder cancer. In August, Celltrion received FDA approval for a Phase 3 trial of CT-P51, a biosimilar to Keytruda (pembrolizumab), further solidifying its position in immuno-oncology.
Company Statement
A Celltrion representative stated, "With the clinical approval of the new pipeline CT-P44 (search) in the world's largest anticancer market, the U.S., we have begun the clinical procedure in earnest, preparing to target the approximately $12.7 trillion daratumumab market. We will do our utmost to secure a portfolio of anticancer antibody therapeutics, including the three targeted anticancer drugs that have already proven their competitiveness in the global market, as well as future immuno-oncology and ADC new drugs."