Biocon-Mylan resubmit applications for 2 biosimilars in Europe

Mumbai: Biocon Ltd on Tuesday said its partner Mylan N.V. has resubmitted marketing authorisation applications for two biosimilars—trastuzumab and pegfilgrastim—with the European Medicines Agency (EMA) that were withdrawn in August due to quality compliance issues at Biocon’s manufacturing plant.

“This (resubmission of applications) follows the earlier withdrawal of both applications in response to the audit of our aseptic drug product facility by the designated European authority. Biocon has completed the Corrective and Preventive Actions (CAPAs), including the facility modifications, in response to the audit observations and expects these to be verified during re-inspection,” Biocon said in a stock exchange filing.

Trastuzumab is a biosimilar of Roche’s breast cancer drug herceptin, while pegfilgrastim is a biosimilar of Amgen’s chemotherapy drug Neulasta. These two biosimilars are part of the six biologic products co-developed by Biocon and Mylan, as part of an exclusive partnership.

In March, Biocon’s drug substance and drug product sites in Bengaluru were inspected by French National Agency for Medicines and Health Products Safety on behalf of the EMA. The inspection was related to Biocon’s pending marketing authorization applications for biosimilars trastuzumab and pegfilgrastim as well as for insulin glargine.

While the French regulator issued good manufacturing practices (GMPs) certificates to the company’s two drug substance manufacturing units, it found quality lapses in the drug product unit.

The company will get GMP compliance certificate for the drug product facility only after a follow-up inspection by EMA to verify the implementation of the corrective and preventive actions for the plant. Until the facility is cleared, Biocon will not get marketing approval for its biosimilars in Europe.

The drug maker has also filed applications for biosimilars trastuzumab and pegfilgrastim with the US Food and Drug Administration (FDA). The US drug regulator had also inspected the company’s Bengaluru plant between 27 March and 7 April this year and made eight observations relating to deviations from GMPs.

On 31 August, the US FDA had extended the target action date for Biocon and Mylan’s biosimilar trastuzumab application by three months to 3 December in order to review some information submitted to the agency. Target action dates are the FDA’s internal deadlines for action on all applications.

On 10 October, the US regulator issued a complete response letter (CRL) for the companies’ application for biosimilar pegfilgrastim, seeking certain additional data before the product gets an approval.

Biocon expects revenue from its biologics portfolio in regulated markets such as the US and Europe to kick in from financial year 2018-19.

At 9:25am, shares of Biocon were up 0.5% at Rs414.15 on the BSE, while benchmark Sensex index was up 0.2% at 33,799.39 points.