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Biocon - Articles and news items

FDA to review Mylan and Biocon’s biosimilar application

Industry news / 17 February 2017 / Niamh Marriott, Digital Editor

The US Food and Drug Administration (FDA) has accepted Mylan and Biocon’s biologics license application for MYL-1401H, a proposed biosimilar to Neulasta…

FDA accepts Mylan and Biocon’s biosimilar biologics license application

Industry news / 12 January 2017 / Niamh Marriott, Digital Editor

This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers…

Mylan and Biocon submit FDA application for Trastuzumab biosimilar

Industry news / 9 November 2016 / Niamh Louise Marriott, Digital Content Producer

Mylan and Biocon have submitted a biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, to the FDA through the 351(K) pathway…

EMA accepts to review Mylan and Biocon’s cancer biosimilar

Industry news / 25 August 2016 / Niamh Louise Marriott, Digital Content Producer

Mylan and Biocon, who co-developed this proposed biosimilar, anticipate that this may be the first MAA for a trastuzumab biosimilar accepted by the EMA…

 

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