Phase 3 Trial Demonstrates Bioequivalence for EirGenix’s Trastuzumab Biosimilar Candidate

Phase 3 clinical trial results confirmed that a trastuzumab biosimilar candidate (EG12014) developed by EirGenix is biosimilar to the reference product (Herceptin), the company said in a statement.

EirGenix, based in Taipei, Taiwan, said it will move forward with plans to submit marketing approval applications to the FDA, the European Medicines Agency, and the Taiwan FDA.

If EG12014 is approved, Sandoz will be in charge of global marketing in the United States and European Union, but not in Taiwan and Mainland China, according to a licensing agreement between Sandoz and EirGenix signed in April 2019.

In 2020, global sales for Herceptin, facing heavy biosimilar competition in Europe, the United States, and elsewhere, dropped 34% from 2019, according to Roche’s annual report. Overall, biosimilar competition eroded $6.34 billion of the company’s international revenues for 2020 and Roche anticipates losing another $5.1 billion to biosimilars in 2021.

The trastuzumab biosimilar candidate, if it is priced below reference, may be well received in Taiwan given that Taiwan’s National Health Insurance paid $57.9 million for Herceptin therapy in 2019.

The phase 3 trial was a multinational, multicenter, randomized, double-blinded study that enrolled 807 women with human epidermal growth factor receptor 2 (HER2)–positive breast cancer. Patients were randomly assigned 1:1 to two treatment groups and were administered anthracycline-based chemotherapy every 3 weeks for 12 weeks.

After receiving chemotherapy, patients were given either EG12014 or the reference drug in combination with paclitaxel once every 3 weeks for 12 weeks. All patients had tumor removal surgery scheduled to take place 3 to 6 weeks after completing neoadjuvant therapy.

During the surgery, investigators collected samples to assess the pathologic complete response (pCR), which was conducted by an independent central laboratory. The study’s primary endpoint of pCR was defined as no invasive cancer in the breast and axillary nodes.

Results of the study demonstrated that EG12014 was bioequivalent to the reference product in terms of clinical response, and the safety profiles between the two were comparable in the preoperative treatment setting.

The trial results come after results from a different study, presented at the National Comprehensive Cancer Network (NCCN) Virtual Annual Conference 2021, showed high early adoption rates for Amgen’s trastuzumab biosimilar, which launched on the US market in July 2019.

Reference

Positive phase III clinical results for EirGenix's proposed trastuzumab biosimilar. News release. EirGenix. March 24, 2021. Accessed March 25, 2021. http://www.eirgenix.com/en/news/show.aspx?num=168