Breast cancer biosimilar approval delayed as US FDA reviews additional information by Biocon, Mylan

NEW DELHI: The US Food and Drug Administration (FDA) has delayed by three months its decision on whether it will approve Biocon and Mylan’s breast cancer biosimilar drug while it reviews additional information submitted by the companies. The approval was earlier expected on September 3.
US FDA has notified Mylan it will extend the target action date for their application of the drug, trastuzumab, to December 3, Biocon told the Bombay Stock Exchange (BSE) after markets closed on Wednesday. This is in order to review some “clarificatory” information submitted to the regulator as part of the application review process, a Biocon spokesperson said.

Biocon and Mylan have together developed the trastuzumab biosimilar, which is a copy of a complex biologic drug developed by Swiss biotech giant Roche.

"This three month extension has no impact on the anticipated timetable for commercialisation of this product in the US," the spokesperson stated.

The extension follows Biocon’s withdrawal of its application for approval for trastuzumab and pegfilgrastim, a drug used to fight infections in chemotherapy patients, in Europe regulatory authorities there sought a re-inspection of its facility for these products. In July, France’s drug regulator had found deficiencies in Good Manufacturing Practices (GMP) at the facility that made these drugs.

Yet, the Bengaluru-based firm said the US FDA’s decision to extend its target action date for the trastuzumab application is not a result of any quality-related concerns.

"The extension of the target action date is linked to the review of the clarificatory information sought as part of the application process. This information is not related to any GMP audit observations at our manufacturing facilities," a company spokesperson told ET.

After it withdrew its application in Europe, Biocon told BSE this was part of the European Medicines Agency’s (EMA) procedural requirements linked to re-inspections.

In July, US FDA’s Oncology Drugs Advisory Committee (ODAC) had unanimously recommended the approval of Biocon and Mylan’s trastuzumab biosimilar.

Share prices of Biocon on BSE closed 0.78% higher at Rs 344.10 a piece on Wednesday, while the benchmark Sensex ended 0.82% higher.