Mylan seeks EMA approval for two biosimilars

By EP News Bureau On Nov 7, 2017

mylan on teva — Mylan has serious concerns about Teva's ability to integrate and efficiently run a combined company, and deliver meaningful shareholder value, he said, adding "there is simply no track record for investors to find". (Reuters)

According to Biocon, it has completed the corrective and preventive actions (CAPAs), including the facility modifications, in response to the audit observations

Biocon said that its partner Mylan has re-submitted marketing authorisation applications with the European Medicines Agency for two biosimilars Trastuzumab and Pegfilgrastim.

“Biocon’s partner Mylan has re-submitted the marketing authorisation applications (MAAs) for our proposed biosimilar Trastuzumab and Pegfilgrastim with the European drug regulator European Medicines Agency (EMA) as per administrative protocol,” the company said in a regulatory filing today.

The company said this follows earlier withdrawal of both the applications in response to observations made by the European regulator.

“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,” it added.

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