Mylan and Biocon announced this morning that their versions of Roche’s Herceptin (trastuzumab) and Amgen’s Neulasta (pegfilgrastim) have been accepted for review by the European Medicines Agency (EMA).
The submissions had previously been withdrawn, following an audit by France’s Agence Nationale de Sécurité du Médicament (ANSM) in March which raised 35 problems in current good manufacturing practice (cGMP) at a fill and finish facility in Bangalore, India.
But in a statement, Mylan – which, if approved, will commercialise the products in the regions – said the Corrective and Preventive Actions (CAPAs) at the facility run by its joint venture partner Biocon have been completed and the firms now await reinspection as part of the regulatory review process.
“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,” said Mylan president Rajiv Malik
He added the partners had been further boosted from the US Food and Drug Administration (FDA) placing the facility on ‘voluntary action indicated’ (VAI) status, closing its audit last month. The Agency had issued a Form 483 with 10 deviations from cGMP in May.
“The Voluntary Action Indicated (VAI) designation we received from FDA gives us further confidence in the readiness of the manufacturing site,” said Rajiv.
Biocon’s CEO Arun Chandavarkar confirmed the resubmissions were due to the completion of the CAPAs and modifications made to the aseptic drug product plant.
“We expect these CAPAs to be verified during inspection as part of the review process.”