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The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.
Biocon, an Indian biotech company, has withdrawn two biosimilar filings in Europe, citing European regulatory requirements. The filings were for biosimilar versions of Roche’s breast cancer drug trastuzumab (Herceptin) and Amgen’s pegfilgrastim (Neulasta), which is given to stimulate white blood cell production in patients receiving myelosuppressive chemotherapy. The launch of these biosimilars will be delayed as a result.
In a statement, the company’s spokesperson said, “Whilst our drug substance facilities for trastuzumab and pegfilgrastim were approved, the European regulatory authorities had informed us of the need for a re-inspection of our drug product facility for these products. The request for withdrawal of the dossiers and re-submission is part of the European Medicines Agency procedural requirements linked to this re-inspection and will be considered by the EMA’s Committee for Medicinal Products for Human Use.”
Biocon’s biosimilar production plant was recently inspected by the French inspecting authority (ANSM); and although no critical observations were mentioned in the final report, the company revealed in a press release that it was required to implement corrective and preventive actions at the facility before a GMP compliance certificate could be issued.
Biocon says it is on track to complete corrective and preventive actions and will seek re-inspection thereafter, followed by the re-submission of its regulatory filings.