Biosimilar approved for breast cancer and metastatic stomach cancer
Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the U.S.
Comment: Biocon withdrew its application to the EU in August 2017. The European Medicines Agency found issues with the Biocon product plant in Bangalore and told Mylan and Biocon that a follow-up inspection would be in order before the trastuzumab biosimilar and a biosimilar of Amgen’s Neulasta will be considered for approval. Biocon decided to withdraw its application.
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