Dr. Mitri on Impact of Trastuzumab Biosimilar FDA Approval

Zahi Mitri, MD, MS, assistant professor of medicine, Oregon Health and Science University, discusses the impact of the FDA-approval of the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst).

In December 2017, the FDA approved the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst) for patients with HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma—the same indications as trastuzumab. MYL-1401O demonstrated an overall response rate (ORR) of 69.6% among women who received the biosimilar in combination with a taxane after 24 weeks, compared with a 64% ORR for patients who received trastuzumab plus a taxane. Mitri says that this approval shows that biosimilars can be developed and tested safely in patients with cancer.

Although a biosimilar will never be the same molecule as the originator drug, if the same efficacy is achieved it can be a positive contribution to the treatment landscape. Looking ahead, Mitri says that if the long-term outcomes between trastuzumab and MYL-1401O are similar, that may change the adoption of these drugs and the whole cost of care. This could be impactful because drugs like trastuzumab cost thousands of dollars, Mitri concludes.