The applications were resubmitted last month after being pulled in August in response to audit observations relating to one of Biocon’s drug facilities.
At the time, Biocon had promised that it would complete corrective and preventive actions by the end the September quarter.
The company said it has now completed the Corrective and Preventive Actions (CAPAs) outlined as a result of the audit observations.
“These applications were resubmitted upon completion of the Corrective and Preventive Actions (CAPAS), including the modifications of our aseptic drug product facility,” said Arun Chandavarkar, CEO & Joint Managing Director, Biocon.
“The CAPAS will be confirmed during reinspection, which will be completed as part of the regulatory review process,” the company said.
Pegfilgrastim is a long-acting version of filgrastim, an established compound that is used to stimulate the production of granulocytes, a type of white blood cell, in cancer patients.
While biosimilars of filgrastim have been approved in the United States and in the European Union, no biosimilar for the long-acting version — Pegfilgrastim — have been approved by either the US or EU authorities.
In fact, two months ago, the USFDA rejected an application by Biocon and Mylan for approval of their pegfilgrastim biosimilar, MYL-1401H.
The acceptance of the application by EU authorities signifies yet another step to potentially getting the compound onto pharmacy shelves.
“Approval of these sites is key in the development and approval process as drug substance manufacture is core to the production of the actual biologic product in GMP compliance,” Biocon said.
The company has already obtained good manufacturing practice (GMP) certificates for its manufacturing facilities in Bangalore.
Mylan President Rajiv Malik said: “Having gone through initial reviews of the applications and after completing the CAPAS from the EMA audit, we are even more confident with the strength of our MAAS.
“Additionally, the Voluntary Action Indicated (VAI) designation we received from FDA gives us further confidence in the readiness of the manufacturing site.
“We now look forward to moving ahead with the rest of the regulatory review process in Europe and to bringing these important treatment options to cancer patients,” he added.
Trastuzumab is used to treat certain HER2-positive breast and gastric Cancers.
Pegfilgrastim is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.