First Trastuzumab Biosimilar, Ogivri, Approved by FDA

The FDA has approved Mylan—Biocon’s trastuzumab biosimilar, MYL-1401O, referenced on Roche’s Herceptin. The drug will be marketed in the United States as Ogivri.

Approval of Ogivri is based on a review of evidence including structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data demonstrating the molecule’s biosimilarity to Herceptin.

“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.”

Approval of Ogivri comes after the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously in July 2017 to approve the biosimilar for all indications of the reference Herceptin. Presenting for the applicant, Hope Rugo, MD, clinical professor and director of the Breast Oncology Clinical Trials Program at the University of California at San Francisco, which conducted a clinical trial of Ogivri, spoke before the ODAC in support of the drug. Rugo stated that trastuzumab is responsible for “curing women who otherwise would not be cured of breast cancer,” and said that the biosimilar would give newly diagnosed patients with HER2-positive metastatic breast cancer the option to start their cancer treatment with a lower-cost alternative to Herceptin.

A regulatory decision on the trastuzumab biosimilar had been expected by the drug’s Biosimilar User Fee Act date of September 3, 2017, but in late August, a Biocon spokesperson announced that the FDA had extended its target action date by 3 months in order to review “clarificatory information” related to the application. While the partnership did not indicate whether the information was pursuant to issues concerning Biocon’s manufacturing facility—troubles with which prompted the withdrawal of marketing applications for both Ogivri and a proposed pegfilgrastim biosimilar from the European Medicines Agency (EMA) until a re-inspection could be completed—Biocon announced on November 20 that the FDA had issued the facility an Establishment Inspection Report in relation to its Good Manufacturing Practice Inspection. On November 30, the partnership announced that the EMA had accepted its resubmitted marketing authorization applications for consideration.

When Mylan—Biocon’s biosimilar will become available to patients in the United States is as yet unclear; Roche has thus far vigorously defended its patents covering the blockbuster Herceptin. The drug maker recently filed a lawsuit against another biosimilar developer, Pfizer, seeking to block the company from releasing a trastuzumab product in the United States. While Mylan and Roche have reached an agreement that will allow Ogivri to be commercialized worldwide, the terms of that agreement (and a date for US commercialization) have not been made public.

Below, Dr Rugo discusses Ogivri and the ongoing pharmacovigilance efforts that will be necessary to track this new biosimilar.