Biocon gets EU regulator nod for trastuzumab biosimilar

Biocon has completed the Corrective and Preventive Actions (CAPAs) out lined as a result of the audit observations.

Dec 01, 2017 08:12 IST India Infoline News Service

Biocon Limited
Mylan N.V. and Biocon announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Applicat- ions (MAA) for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim.

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 productionof the actual bio logic product in GMP compliance.


On Thursday, the stock ended at Rs432.25, up by Rs4.45 or 1.04% from its previous closing of Rs427.8 on the BSE. The scrip opened at Rs428 and touched a high and low of Rs436.45 and Rs423.4 respectively.

Biocon is a fully integrated biopharma player with API manufacturing facilities, strong capabilities in biologics and branded generics business in India. Its potential segment of biologicals have contributed 12% of turnover of FY17.

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