Mylan seeks EMA approval for 2 biosimilars
New Delhi: Biocon said that its partner Mylan has re-submitted marketing authorization applications with the European Medicines Agency for two biosimilars Trastuzumab and Pegfilgrastim.
"Biocon's partner Mylan has re-submitted the marketing authorization 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.
The company said this follows the 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.
approval biosimilars CAPA corrective and preventive actions EMA European Medicines Agency indian pharma news marketing authorization Mylan observations Pegfilgrastim pharma news pharma news india Trastuzumab withdrawalSource : PTI