Celltrion and Teva Announce BLA for Rituximab Biosimilar CT-P10

Celltrion and Teva announced today that the FDA has accepted the companies’ Biologics License Application (BLA) for CT-P10, a proposed rituximab biosimilar. FDA regulatory action is expected in early 2018.

The BLA includes efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) data demonstrating the similarity of CT-P10 and the reference product (Rituxan, which is approved to treat patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis). Trials were conducted in over 600 patients and include up to 104 weeks of data.

In February, the European Commission approved CT-P10, and the product has since launched in the United Kingdom, Germany, the Netherlands, and Spain, where the treatment is marketed under the names Tuxella, Ritemvia, Blitzima, and Truxima, respectively, for specific indications. CT-P10 is also available to patients in the Republic of Korea.

Woo Sung Kee, CEO of Celltrion, said in the companies’ announcement: “CT-P10…is continuing to build a solid track record since its [EU] launch earlier this year, and has provided patients with access to a high-quality treatment option and has offered great saving in healthcare costs. I am hopeful that CT-P10 will bring similar benefits to the United States when approved.”

In addition to providing such benefits to patients and health systems, Celltrion, along with its US commercial partner, Teva, certainly hopes to capture significant sales with its biosimilar of the world’s second highest-earning drug; Rituxan generated $7 billion in sales in 2016 alone.

News of Celltrion’s BLA comes just ahead of a planned initial public offering (IPO) for Celltrion Healthcare, the marketing affiliate of Celltrion Inc. The marketing company, which exclusively markets, sells, and distributes the biosimilar products produced by Celltrion, plans to sell 24.6 million shares in an effort to raise the equivalent of over $700 million. The IPO price will be set on or around July 17. Celltrion Healthcare’s representatives are reported as saying that the listing should help build direct sales networks for the biosimilar manufacturer’s products overseas as the South Korean drug maker seeks to make further inroads into lucrative biosimilars markets.