Celltrion, Teva File BLA for CT-P6, a Trastuzumab Biosimilar

Celltrion and Teva announced today that the FDA has accepted for review the companies’ Biologics License Application (BLA) for CT-P6, a proposed trastuzumab (Herceptin) biosimilar.

Woo Sung Kee, CEO of Celltrion, said, “Following on the heels of our global success with…our infliximab biosimilar, which has brought affordable and effective biologic treatment to many patients around the world with proven similarity of quality, efficacy and safety to the reference product, we are confident to submit a comprehensive package of quality, nonclinical and clinical data of CT-P6 for FDA review.” Teva’s senior vice president and general manager of the company’s oncology division, Paul Rittman, added, “we look forward to the opportunity to leverage Teva’s strong legacy and US commercial presence in [oncology] to bring additional biosimilar treatment options to patients.”

The BLA for CT-P6 includes efficacy, safety, immunogenicity, pharmacodynamic, and pharmacokinetic data from trials conducted in over 500 patients in 22 countries. A recent phase 3 equivalence trial of CT-P6 as a neoadjuvant treatment in human epidermal growth factor receptor 2-positive early breast cancer demonstrated equivalent efficacy of the proposed biosimilar to the reference trastuzumab, with a similar proportion of patients achieving pathological complete response with CT-P6 and the reference trastuzumab.

Today’s BLA is the second in as many months from the Celltrion and Teva partnership; the companies announced in June that the FDA had accepted for review a BLA for CT-P10, a proposed biosimilar to rituximab (Rituxan). A 2016 partnership announcement between the 2 companies included a deal to commercialize CT-P6 and CT-P10 in the United States and Canada. Celltrion says that it expects FDA regulatory action on both applications in the first half of 2018.

If CT-P6 and CT-P10 are both approved, the companies will be poised to compete for shares of the substantial—and growing—markets for trastuzumab and rituximab. Sales of the reference trastuzumab hit $6.75 billion in 2016 (up 3.7% from 2015), and sales of rituximab totaled $8.58 billion (up by 2.7%).

The Teva—Celltrion partnership may well challenge the Mylan–Biocon partnership for market share of trastuzumab—the latter’s MYL-1401O, another proposed biosimilar to the reference Herceptin, is expected to receive FDA approval in September after a unanimous recommendation by the FDA’s Oncologic Drugs Advisory Committee earlier this month.