Biocon, Mylan apply again for EU approval for cancer drugs trastuzumab, pegfilgrastim

Biocon said its partner Mylan has resubmitted the marketing application for two substances used to treat cancer — trastuzumab and pegfilgrastim — before European authorities after making changes to their production facilities.

The drug applications before the European Medicines Agency (EMA) were withdrawn in August after the authorities refused to issue approval without reinspecting the plants.

The EMA had issued a list of Corrective and Preventive Actions (CAPAs) to be carried out at the plant after conducting an audit of the facility.

“Biocon has completed the CAPAs, including the facility modifications, in response to the audit observations and expects these to be verified during re-inspection,” the Indian drug maker said.

Biocon’s shares had fallen by around 6% when it was forced to withdraw the application in August.

The drugs are called biosimilars, as they imitate the actions of compounds produced by the human body.

Trastuzumab was developed by Roche and is one of the most commonly used drugs to treat HER2-positive breast cancer. It is sold under the brand Herceptin and Herclon in India.