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Amgen and Allergan Report Submission of BLA to the US FDA for its ABP 798 (biosimilar- rituximab)

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Amgen and Allergan Report Submission of BLA to the US FDA for its ABP 798 (biosimilar- rituximab)

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  • The BLA submission is based on two studies assessing ABP 798 vs Rituxan which resulted in analytical- PK and clinical data showing no clinically meaningful differences between products
  • In Dec- 2011 Amgen and Allergan globally collaborated to develop and commercialize four oncology antibody biosimilar medicines
  • ABP 798 is a mAb CD20-directed cytolytic mAb approved for RA- non-Hodgkin's lymphoma- chronic lymphocytic leukemia (CLL) in the US and EU. Additionally- Amgen has 10 biosimilars in its portfolio four approved in the US and three in EU

Click here to read full press release/ article | Ref: Amgen | Image: Behance


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