FDA Approves Biosimilar Trastuzumab for HER+ Breast Cancer

[Lani]

FDA Approvals
FDA Approves Biosimilar Trastuzumab for HER+ Breast Cancer


December 01, 2017


The first biosimilar product that corresponds to trastuzumab (Herceptin, Genentech/Roche) has been approved by the US Food and Drug Administration (FDA).
The product, trastuzumab-dkst (Ogivri, Mylan GmbH) is indicated for use in the treatment of human epidermal growth factor receptor (HER)–positive (HER+) breast cancer and also HER2+ metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
This is the second biosimilar approved by the FDA in recent months. Its approval follows the approval in September 2017 of a biosimilar bevacizumab product (corresponding to Avastin [Genentech/Roche]).
Both approvals follow a meeting of the Oncologic Drugs Advisory Committee at which experts voted unanimously in favor, having found both biosimilar products to be pure, potent, and safe enough to be recommended for approval.

A large phase 3 clinical trial, known as HERITAGE and conducted in 500 patients with HER2+ breast cancer, found that this biosimilar trastuzumab had "comparable safety and efficacy" when compared to the reference branded product Herceptin; this trial was presented at the American Society of Clinical Oncology 2016 annual meeting.
The main difference between the biosimilar and the reference product is price, with hopes that the biosimilars will be about 30% cheaper.
"The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients," said FDA Commissioner Scott Gottlieb, MD. "We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs."
The agency also noted in a press release that its approval of the new biosimilar trastuzumab-dkst "is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Ogivri is biosimilar to Herceptin."
"Ogivri has been approved as a biosimilar, not as an interchangeable product," the agency added.