
Biocon Withdraws Breast Cancer Biosimilar Filings in Europe
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Biocon, an Indian biotech company, has withdrawn two biosimilar filings in Europe, citing European regulatory requirements.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
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
Biocon
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