BRIEF—EMA accepts Mylan and Biocon's proposed biosimilars trastuzumab and pegfilgrastim

The European Medicines Agency has accepted for review Mylan's Marketing Authorization Applications (MAA) for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim, which are being developed with India’s Biocon.

Trastuzumab, the active ingredient of Roche’s Herceptin, is used to treat certain HER2-positive breast and gastric cancers.

Pegfilgrastim, Amgen’s Neupogen, 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.

The EMA acceptance of the submissions follows an earlier withdrawal of both applications in response to an audit conducted by the European inspecting authority of Biocon's drug product facility.

Biocon has 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.

Good Manufacturing Practice (GMP) compliance certificates for Biocon's two drug substance manufacturing facilities in Bangalore have been issued previously.

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.