All Data
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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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