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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

Press Trust of India  |  New Delhi 

Biocon's facility. Photo: Company's website
Biocon's facility. Photo: Company's website

Biotechnology firm on Friday said European drug regulator has accepted its partner Mylan's for two proposed biosimilars.

"The (EMA) has accepted for review Mylan's (MAA) for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim," 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. 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 had re-submitted with the EMA for the two biosimilars.

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

First Published: Fri, December 01 2017. 12:54 IST
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