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Find Clinical Drug Pipeline Developments & Deals by Samsung Bioepis

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            Lead Product(s): Denosumab

            Therapeutic Area: Musculoskeletal Product Name: SB16

            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 December 14, 2020

            Details:

            Prolia is Amgen’s treatment for skeletal diseases, osteoporosis and bone loss of cancer patients. The company began to conduct the trial in November, comparing the efficacy and safety of SB16 with the original drug on 432 post-menopausal osteoporosis patients in six countries.

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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): Denosumab

            Therapeutic Area: Musculoskeletal Product Name: SB16

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 10, 2020

            Details:

            The Phase 1 clinical trial for SB16 (denosumab) is a randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity between SB16 and Prolia® in healthy male volunteers.

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            Lead Product(s): Ranibizumab

            Therapeutic Area: Ophthalmology Product Name: SB11

            Highest Development Status: Phase III Product Type: Large molecule

            Recipient: Biogen

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 06, 2020

            Details:

            European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis® (ranibizumab).

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            Lead Product(s): Bevacizumab

            Therapeutic Area: Oncology Product Name: Aybintio

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 15, 2020

            Details:

            The Incheon, Republic of Korea–based company said the study results supported preexisting evidence in support of equivalence between Aybintio and reference bevacizumab in patients with metastatic or recurrent nonsquamous non–small cell lung cancer.

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            Lead Product(s): Trastuzumab

            Therapeutic Area: Oncology Product Name: Ontruzant

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 10, 2020

            Details:

            ONTRUZANT® (trastuzumab) is Samsung Bioepis’ first oncology treatment and second product to be launched in Brazil followed by BRENZYS™, both in partnership with Bio-Manguinhos/Fiocruzi and Bionovis.

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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): Bevacizumab,Carboplatin,Paclitaxel

            Therapeutic Area: Oncology Product Name: Aybintio

            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 26, 2020

            Details:

            AYBINTIO®, a biosimilar candidate referencing Avastin®i (bevacizumab), is Samsung Bioepis’ second oncology biosimilar to be recommended for marketing authorization by the European Medicines Agency.

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            Lead Product(s): Aflibercept

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2020

            Details:

            SB15 received the green light from health authorities in eight countries, including phase three clinical trials in South Korea and the United States. SB15 is a biosimilar candidate of Regeneron Pharmaceuticals' Eylea, to treat age-related (wet) macular degeneration (AMD).

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