Dr. Esteva on the Impact of the Trastuzumab Biosimilar Approval

Francisco J. Esteva, MD, PhD
Published: Friday, Jul 06, 2018



Francisco J. Esteva, MD, PhD, medical oncologist, New York University’s Perlmutter Cancer Center, discusses the impact of the approval of the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst).

The approval of the trastuzumab biosimilar will hopefully give additional options for the treatment of [patients with] HER2-positive disease at a lower cost, says Esteva. As it stands only one of them is approved. Physicians need more approvals from different biosimilars to reduce the cost of care, both in the United States and globally.

A biosimilar has to demonstrate the same safety and efficacy as trastuzumab. There are at least 5 companies that Esteva knows of that are working on trastuzumab biosimilars. These are going through regulatory approvals in Europe and the United States. If those studies continue to show similar efficacy, they will be approved, states Esteva. Whether physicians use them or not is up to the physicians, the patients, and the payers. There is only one approved biosimilar in the United States, and it likely won’t be commercialized until next year, explains Esteva.


Francisco J. Esteva, MD, PhD, medical oncologist, New York University’s Perlmutter Cancer Center, discusses the impact of the approval of the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst).

The approval of the trastuzumab biosimilar will hopefully give additional options for the treatment of [patients with] HER2-positive disease at a lower cost, says Esteva. As it stands only one of them is approved. Physicians need more approvals from different biosimilars to reduce the cost of care, both in the United States and globally.

A biosimilar has to demonstrate the same safety and efficacy as trastuzumab. There are at least 5 companies that Esteva knows of that are working on trastuzumab biosimilars. These are going through regulatory approvals in Europe and the United States. If those studies continue to show similar efficacy, they will be approved, states Esteva. Whether physicians use them or not is up to the physicians, the patients, and the payers. There is only one approved biosimilar in the United States, and it likely won’t be commercialized until next year, explains Esteva.



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