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Private company

SAMSUNG BIOEPIS

SAMSUNG BIOEPIS is a company based in Incheon founded in 2012.1

삼성바이오에피스(영어: Samsung Bioepis, 三星바이오에피스)는 대한민국의 제약 기업으로, 바이오시밀러를 개발한다.2 From the Korean Wikipedia, CC BY-SA 4.0

Last updated Oct 21, 2026.

Overview

Feb 28, 2012Founded1

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Timeline

  1. Feb 28, 2012Founded Founded1

Calendar

Drug trials and FDA: recently

  1. Sep 22, 2026Phase 2 trial completed Phase 2 trial of SB15 PFS in Neovascular Age-related Macular Degeneration: primary completion Sep 22, 2026, no results posted yet (ClinicalTrials.gov NCT07844343).3
  2. Mar 31, 2026Phase 2 trial completed Phase 2 trial of SB11 PFS in Age-Related Macular Degeneration: primary completion Mar 31, 2026, no results posted yet (ClinicalTrials.gov NCT07550504).4
  3. Mar 10, 2026Phase 3 trial completed Phase 3 trial of SB27 and Keytruda in Non-small Cell Lung Cancer Stage IV: primary completion Mar 10, 2026, no results posted yet (ClinicalTrials.gov NCT06348199).5
  4. Nov 28, 2025FDA approval FDA approved Epysqli (eculizumab-aagh), a biologic (BLA 761340).6
  5. Oct 29, 2025FDA approval FDA approved Denosumab-Dssb, a biologic (BLA 761392).7
  6. Apr 30, 2025FDA approval FDA approved Pyzchiva (ustekinumab-ttwe), a biologic (BLA 761373).8
  7. Feb 13, 2025FDA approval FDA approved Denosumab-Dssb, a biologic (BLA 761392).9
  8. Jul 19, 2024FDA approval FDA approved Epysqli (eculizumab-aagh), a biologic (BLA 761340).10

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Sources

The numbers on this page point here. Each one links to the record it came from.

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