Sandoz and EirGenix to Partner on Biosimilar Trastuzumab, EG12014

Sandoz has announced that it has entered into a partnership with Taiwan-based biotechnology manufacturing and development company EirGenix, Inc, for a proposed trastuzumab biosimilar referencing Herceptin.

Under the terms of the deal, EirGenix will develop and manufacture the biosimilar, while Sandoz will commercialize the product upon approval in all markets other than China and Taiwan. EirGenix will receive an upfront payment, milestone payments, and a share of profits from the biosimilar.

Sandoz indicated in a statement that this collaboration will allow the company to use its in-house resources to perpetuate its internal pipeline while further expanding its oncology portfolio and developing its hospital presence.

“Every year, approximately 300,000 people worldwide are diagnosed with HER2-positive breast cancer, which tends to spread more quickly than HER2-negative tumors, making swift treatment important. While targeted therapy is available, high out-of-pocket costs lead to limited treatment in the [United States,] and reimbursement issues have resulted in varying uptake in Europe,” said Stefan Hendriks, global head of biopharmaceuticals for Sandoz, in a statement. “Introducing biosimilars can help create earlier and expanded access to this important medicine, which is why I am so excited about the potential for this collaboration.”

The proposed biosimilar, EG12014, is currently in phase 3 clinical development, and EirGenix reports that the phase 3 trial in patients with breast cancer, begun in October 2018, will enroll a total of 800 patients. Patients will receive epirubicin and cyclophosphamide followed by either EG12014 or its reference plus paclitaxel. All patients will be scheduled for surgery 3 to 6 weeks after completion of neoadjuvant chemotherapy. The primary end point analysis is expected to be completed in the second half of 2020.

In May 2017, the company announced that the proposed biosimilar had demonstrated bioequivalence in a phase 1 clinical trial. The study was a double-blind, randomized, parallel group, 3-arm study in 84 healthy male volunteers. The study investigated the pharmacokinetic (PK) similarity between EG12014 and EU- and US-licensed reference Herceptin. According to the company, the study met its primary PK end point.

EirGenix also reports that it is developing a pertuzumab biosimilar referencing Perjeta, a bevacizumab biosimilar referencing Avastin, and an undisclosed biosimilar—all of which are in the preclinical phase—as well as novel drug agents.