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Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: SB11
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2020
Details:
If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in Europe; BENEPALI™, IMRALDI™ and FLIXABI™.
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Lead Product(s): Ranibizumab
Therapeutic Area: Ophthalmology Product Name: SB11
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 November 12, 2020
Details:
SB11 is the sixth biosimilar product and the first eye disease treatment that Samsung Bioepis developed after three autoimmune disease treatments (SB2, SB4, SB5) and two tumor disease treatments (SB3, SB8).
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Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
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 August 31, 2020
Details:
ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome.
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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.
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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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