Samsung Bioepis

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Samsung Bioepis Begins Phase 3 Trial for Aflibercept Biosimilar

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

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Samsung Bioepis Secures Positive CHMP Opinion for Aybintio

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.

Samsung Bioepis

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Samsung Bioepis' Ophthalmology Biosimilar Candidate Receives Clinical Approvals in 8 Markets

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).

Samsung Bioepis

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

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.

Samsung Bioepis

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Merck, Samsung Join Newly Crowded Market for Herceptin Biosimilars

Lead Product(s): Trastuzumab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Merck & Co. Inc.

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 15, 2020

Details:

ONTRUZANT is being launched in the U.S. by Merck as part of a development and commercialization agreement with Samsung Bioepis.

Samsung Bioepis

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Mundipharma Enters Partnership With Samsung Bioepis to Expand Biosimilars Into Hong Kong and Taiwan

Lead Product(s): Adalimumab

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Large molecule

Recipient: Mundipharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership January 16, 2020

Details:

The partnership covers Samsung Bioepis’ biosimilar candidates in the field of immunology and oncology, including SB5 (adalimumab), SB4 (etanercept), SB3 (trastuzumab), and SB8 (bevacizumab).