Amgen and Allergan Report Submission of BLA to the US FDA for its ABP 798 (biosimilar, rituximab)
Amgen Reports In-Favor Uphold of its Two Patents for Repatha from Delaware Jury
Shots:
- 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