The European Medicines Agency (EMA) has accepted to review Mylan’s marketing authorisation applications (MAA) for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim.
The proposed biosimilars have been co-developed by Mylan and Indian biopharmaceutical company Biocon.
Biosimilar trastuzumab is used for the treatment of certain human epidermal growth factor receptor 2 (HER2)-positive breast and gastric cancers.
“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.”
Pegfilgrastim is used to reduce the duration of neutropenia and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy for certain types of cancer.
Neutropenia is caused by the low count of neutrophils, a type of white blood cell.
The current EMA acceptance follows an earlier withdrawal of both applications in response to an audit conducted by the European inspecting authority of Biocon’s drug product facility.
The Indian firm has currently completed the Corrective and Preventive Actions (CAPAs) outlined as a result of the audit observations.
The CAPAs will be confirmed during reinspection, which will be completed as part of the regulatory review process.
Previously, Biocon’s two drug substance manufacturing facilities in Bangalore, India, has received good manufacturing practice (GMP) compliance certificates.
Approval of the production facilities is important in the development and approval process as drug substance manufacture plays a major role in the production of the actual biologic product in GMP compliance.
Mylan president Rajiv Malik said: “We are extremely pleased with the acceptance of our MAAs.
“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.”
Last month, Biocon’s partner Mylan resubmitted the MAAs for the proposed biosimilars with the EMA as per the administrative protocol.
