Amgen Has Filed for EU Approval for Herceptin® (Trastuzumab) Biosimilar

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During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated that Amgen has filed for approval in the EU for their ABP 980 biosimilar (trastuzumab).  Mr. Meline also indicated that Amgen is looking to file for approval in the U.S., but his slides did not provide information on the timing of that filing.  We have previously reported that Amgen is developing ABP 980 with Allergan.

Stay tuned to Big Molecule Watch for further updates.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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