Samsung Bioepis Co., Ltd. is a South Korean biopharmaceutical company headquartered in Incheon, South Korea, focused on developing and manufacturing high-quality biosimilars. While primarily known for biosimilars in immunology and oncology, the company has expanded into neuroscience including neurodegenerative diseases.
| Attribute |
Value |
| Founded |
2012 |
| Headquarters |
Incheon, South Korea |
| Parent |
Samsung Biologics (Samsung C&T) |
| Stock |
KRX: 321550K |
| CEO |
Christopher Hansung Ko |
| Drug |
Mechanism |
Stage |
Status |
| SB-303 |
Anti-amyloid beta biosimilar |
Preclinical |
Research |
| SB-309 |
Anti-tau antibody biosimilar |
Discovery |
Early research |
| Drug |
Mechanism |
Stage |
Status |
| SB-401 |
Alpha-synuclein targeting |
Discovery |
Early research |
Samsung Bioepis operates through:
- Biosimilar Development: Developing high-quality biosimilars for global markets
- Contract Manufacturing: Manufacturing biologic drugs for pharmaceutical partners
- Novel Drug Discovery: Expanding into novel drug development for unmet medical needs
- Bristol Myers Squibb: Partnership for biosimilar development (ended)
- Biogen: Partnership for immunology biosimilars
- Samsung Biologics: Manufacturing infrastructure
Samsung Bioepis represents a significant player in making biologic therapies accessible:
- Biosimilar cost reduction: Biosimilars typically cost 15-30% less than reference biologics
- Manufacturing scale: Samsung Biologics' massive manufacturing capacity enables global supply
- Regulatory expertise: Experience navigating FDA, EMA, and Korean regulatory pathways
- Cold chain capabilities: Advanced capabilities for temperature-sensitive biologic products
Samsung Bioepis has announced expansion into neurodegenerative diseases:
| Target |
Approach |
Timeline |
| Alpha-synuclein aggregation inhibitors |
Small molecule |
2027 |
| Tau propagation blockers |
Antibody therapy |
2028 |
| Neuroinflammation modulators |
Biologic |
2028-2029 |
- Total capacity: 620,000 liters (largest in the world)
- Facilities: 4 large-scale manufacturing plants in Incheon
- Inspection track record: First Korean company to receive FDA pre-approval inspection
- EMA certification: Fully compliant with EU manufacturing standards
- ISO certifications: ISO 9001, ISO 14001, ISO 45001
- GMP compliance: FDA, EMA, PMDA, WHO prequalification
- Continuous verification: Real-time batch monitoring and quality controls
Samsung Bioepis ranks among the top global biosimilar developers:
| Rank |
Company |
Market Share |
| 1 |
Samsung Bioepis |
~30% |
| 2 |
Sandoz |
~25% |
| 3 |
Mylan/Teva |
~20% |
| 4 |
Others |
~25% |
- Manufacturing excellence: State-of-the-art facilities with industry-leading yields
- Speed to market: Accelerated development timelines
- Global reach: Presence in 90+ countries
- Portfolio breadth: 30+ biosimilar programs in development
- Revenue (2024): ~₩1.5 trillion (~$1.1B)
- R&D investment: ~15% of revenue
- Profitability: Profitable since 2022
- Market cap: ~₩5 trillion (~$3.7B)