Samsung Bioepis and Biogen Report the FDA's Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis
Shots:
- The US FDA has accepted for review the BLA of SB11- a proposed biosimilar referencing Lucentis (ranibizumab)
- The EMA has accepted for review the MAA of SB11 in Oct’2020. If approved- SB11 will add to the biosimilars portfolio developed under the collaboration of Samsung Bioepis and Biogen including Benepali- Imraldi & Flixabi
- In Nov’2019- Samsung Bioepis entered into a commercialization agreement with Biogen for 2 ophthalmology biosimilar candidates- SB11 (ranibizumab) & SB15 (aflibercept) in the US- Canada- Europe- Japan & Australia. Ranibizumab is an anti-VEGF therapy for retinal vascular disorders
Click Here Ref: Samsung Bioepis | Image: Biogen
Click here to read the full press release
Tags
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com