European drug regulator accepts Mylan's applications for 2 biosimilars

EMA acceptance of submissions follows an earlier withdrawal of both applications in response to an audit conducted

Biotechnology firm Biocon on Friday said European drug regulator European Medicines Agency has accepted its partner Mylan's marketing authorisation applications for two proposed biosimilars.

"The European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorisation Applications (MAA) for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim," Biocon said in a BSE filing.

"EMA acceptance of the submissions follows an earlier withdrawal of both applications in response to an audit conducted by the European inspecting authority of Biocon's drug product facility. Biocon has completed the corrective and preventive actions (CAPAs) outlined as a result of the audit observations", it said further.

The CAPAs will be confirmed during re-inspection, which will be completed as part of the regulatory review process, it added.

Last month Mylan had re-submitted marketing authorisation applications with the EMA for the two biosimilars.

Shares of Biocon were trading 2.44 per cent higher at Rs 442.80 in morning trade on BSE today.