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Biocon withdraws applications to sell two cancer drugs in Europe

This comes on the back of drug regulators seeking re-inspection of Biocon's manufacturing facilities

Biocon's facility. Photo: www.biocon.com
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Biocon's facility. Photo: Company's website

Aneesh Phadnis Mumbai

Biocon, the biopharmaceutical major, has withdrawn its earlier applications to sell two anti-cancer drugs in Europe, as drug regulators have sought re-inspection of its manufacturing facilities.

Last year, the European Medicine Agency (EMA) accepted for review Biocon's applications to launch biosimilars Trastuzumab and Pegfilgrastim. Biocon is co-developing these two drugs for US and European countries in partnership with drug maker Mylan. Biosimilars are copies of biologic drugs.

However, the company's plan to launch the two drugs in Europe in early 2018 is now facing hurdles. Last month, France's drug regulator said it had found lapses in the company's manufacturing unit in Bengaluru