The U.S. Food and Drug Administration postponed a decision on MYL-1401O, a biosimilar version of Roche Holding AG's cancer drug Herceptin.
Mylan NV and Biocon Ltd, who will market the biosimilar, said the regulator extended the target action date by three months to Dec. 3 to review some of the clarifications submitted by the companies.
The U.S. FDA's Oncologic Drugs Advisory Committee has already recommended approval for MYL-1401O for treating HER2-positive breast cancer.
Mylan's partner Biocon has been facing regulatory hurdles at its Bangalore, India, site where the biosimilar will be manufactured. The U.S. agency recorded eight violations at the facility during inspections from March to April.
Biocon also withdrew its application for the biosimilar with the European Medicines Agency after France's drugs regulator flagged issues at the Bangalore site.
Biocon says the extension would have no impact on the commercialization timeline of the biosimilar in the U.S.