Mylan's EU biosimilar ambition hit by GMP issues at Biocon plant
An inspection in March of Biocon’s facilities in Bangalore by France’s Agence Nationale de Sécurité du Médicament (ANSM) raised 35 problems in GMP relating to the drug product manufacture for three biosimilars.
Eleven of these deficiencies were deemed “major” by the Agency in its non-compliance report (NCR, embedded below). These related to environmental monitoring, training, OOS results management, cleaning validation, process validation, vendor qualification, media fill test, cross-contamination risk, batch manufacturing record, differential pressure alarms’ management, and access management in SAP for batch certification.
The inspection was conducted as part of the EMA’s assessment of the marketing authorisation application (MAA) of three biosimilars submitted for review by Biocon’s biosimilar development and commercialisation partner Mylan.
In Europe, Mylan is looking to take on Amgen’s Neulasta (pegfilgrastim), Roche’s Herceptin (trastuzumab) and Sanofi’s Lantus (insulin glargine) with its versions Fulphila, Ogivri and Semglee, respectively.
However, the ANSM recommended these biosimilars “should not be approved while this NCR is in force” and no batch of the three products manufactured prior to the issuance of the report “should be supplied to Europe.”
In a statement sent to Biopharma-Reporter, Biocon said ANSM has reviewed a proposed corrective and preventive actions (CAPA) plan and “the receipt of a GMP compliance certificate for the drug product facility will require a follow up inspection from ANSM to verify implementation [of the plan].”
The firm noted the ANSM had, however, issued GMP compliance certificates for its two drug substance manufacturing facilities in Bangalore.
This covers the preparation and storage of the Master Cell Bank (MCB) and Working Cell bank (WCB), manufacture and quality control operations for the trastuzumab API, and the quality control operations of the pegfilgrastim drug substance.