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Amgen and Allergan file FDA application for new oncology biosimilar
Amgen and Allergan have filed a license application to the US Food and Drug Administration (FDA) for one of the four cancer therapies they are currently working on collaboratively.
The pharmaceutical firms have filed a submission for their ABP 980, which is similar to current cancer treatment trastuzumab (marketed under the name Herceptin).
ABP 980 is designed to target several types of breast and gastric cancer, with phase III trial data demonstrating its efficacy and safety in women with HER2-positive early breast cancer.
Sean E Harper, executive vice-president of research and development at Amgen, commented: "The submission of ABP 980 for FDA review is an exciting milestone and speaks to our joint commitment with Allergan to deliver quality oncology biosimilars to patients."
Amgen and Allergan are also collaborating on three other oncology biosimilars, while Amgen has ten in its own portfolio that are currently in various stages of development.
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