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Biocon, the biopharmaceutical major, has withdrawn its earlier applications to sell two anti-cancer drugs in Europe, as drug regulators have sought re-inspection of its manufacturing facilities.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

A Biocon spokesperson said while its drug substance facilities for Trastuzumab and Pegfilgrastim were approved, European regulatory authorities informed the company about the need for a re-inspection of drug product facilities for these two products.

"The request for withdrawal of the dossiers and re-submission is a part of the EMA procedural requirements linked to this re-inspection and will be considered by the EMA's Committee for Medicinal Products for Human Use. We are on track to complete our corrective and preventive actions by the end of this quarter and it is our intent to seek re-inspection and re-submission thereafter," the spokesperson said.

Last month Biocon chairperson Kiran Mazumdar-Shaw said the French regulator's observations would not pose hurdles for product approval in the US. The US Food and Drug Administration's Oncologic Drug Advisory Committee recommended approval of Trastuzumab, Biocon's proposed biosimilar, indicated for certain types of breast cancer.

Biocon's stock fell 5.8 per cent to close at Rs 328.80 at the BSE on Wednesday.