Celltrion/Teva and Amgen/Allergan Announce FDA Submissions for Proposed Biosimilars of Herceptin®

Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer.

First, Celltrion and Teva announced that the FDA has accepted for review a BLA for CT-P6, a proposed trastuzumab biosimilar. The press release indicates that Celltrion and Teva entered into an exclusive partnership last year to commercialize CT-P6, as well as another biosimilars candidate. According to the press release: “The BLA for CT-P6 includes data for CT-P6 and reference trastuzumab in terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK). These trials were conducted in over 500 patients in 22 countries.”

Second, Amgen and Allergan announced the submission of a BLA to the FDA for ABP980, also a proposed biosimilar to Herceptin®. The press release indicates that this is the second oncology biosimilar candidate to be submitted to FDA for approval as part of Amgen and Allergan’s ongoing collaboration. The press release describes the data that was submitted as follows:  “The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase 3 comparative efficacy, safety and immunogenicity study was conducted in adult female patients with HER2-positive early breast cancer.”

Stay tuned to Big Molecule Watch for further developments.