Complete response letter from FDA for biosimilar trastuzumab .- Amgen.
Amgen, in a two-sentence announcement said it received a complete response letter for its trastuzumab biosimilar (provisionally Kanjinti) of Herceptin it has developed with Allergan. This CRL marks the third Herceptin biosimilar that has been held up by the FDA but they have been more successful in Europe.
Biosimilar pharmaceutical companies have been quick to develop their own versions of Herceptin which still achieved $2.5 billion in U.S. sales in 2017 and $7 billion worldwide. Mylan and Biocon, Pfizer and now Amgen have all have had their initial applications rejected by the FDA .
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