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    FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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              Samsung Bioepis

              • Development Update

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              KOREA, REPUBLIC OF Korea, Republic Of

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              Chinaplas 2020

              Participation Not Confirmed

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              Samsung Bioepis Begins Phase 3 Trial for Aflibercept Biosimilar

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              Lead Product(s): Aflibercept

              Therapeutic Area: Ophthalmology Product Name: SB15

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 30, 2020

              Details:

              The randomized, double-masked, parallel group, multicenter study will compare SB15 and reference Eylea on safety, efficacy, pharmacokinetics, and immunogenicity.

              Samsung Bioepis

              • Development Update

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              KOREA, REPUBLIC OF Korea, Republic Of

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              Chinaplas 2020

              Participation Not Confirmed

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              Samsung Bioepis Phase 3 Trial of Ranibizumab Biosimilar Candidate, SB11 to Treat Namd Meets Primary Endpoints

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              Lead Product(s): Ranibizumab

              Therapeutic Area: Ophthalmology Product Name: Undisclosed

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 18, 2020

              Details:

              In a Phase 3 study, SB11 demonstrated equivalent efficacy in terms of change in best corrected visual activity (BCVA) at Week 8 and central subfield thickness (CST) at Week 4 to reference ranibizumab LUCENTIS®i in patients with neovascular age-related macular degeneration.

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