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Samsung Bioepis and Biogen Report the FDA's Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis

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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 

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