Samsung Bioepis Co., Ltd.


Biopharmaceutical company focused on development, manufacture and commercialization of biosimilar and novel biologic therapeutics. Operates R&D and regulatory programs across multiple therapeutic areas (immunology, oncology, ophthalmology, hematology, nephrology, endocrinology), pursues partnerships for global commercialization, and publishes market and policy analysis. Publicly reports ESG and quality-management activities including ISO certifications and a commitment to renewable energy initiatives.

Industries

biotechnology
pharmaceutical

Nr. of Employees

large (251-1000)


Patents

Syringe cap

US-D979053-S1

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Methods for overcoming glutamine deprivation during mammalian cell culture

US-11124760-B2

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Control of protein glycosylation by culture medium supplementation and cell culture process parameters

US-10676772-B2

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Injector for medicine

US-D867583-S1

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Injector body

US-D864379-S1

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Injector for medicine

US-D855176-S1

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Products

Portfolio of biosimilar therapeutics

A portfolio of biosimilar monoclonal antibodies and protein biologics across immunology, oncology, ophthalmology, hematology, nephrology and endocrinology with multiple regulatory approvals across global markets.


Services

Partnering for regional commercialization, licensing and market access for biologic therapeutics.

Collaborative R&D and licensing for development and manufacturing of bispecific and dual-payload ADC therapeutics.

Quarterly market reports and analysis on biosimilar approvals, launches, pricing and policy impacts.

Expertise Areas

  • Biosimilar development
  • Biologic therapeutics and ADC development
  • Clinical trial management
  • Regulatory submissions and global approvals
  • Show More (6)

Key Technologies

  • Monoclonal antibody therapeutics
  • Antibody-drug conjugates (ADCs)
  • Mammalian cell culture and bioprocessing
  • Protein bioassays and physicochemical characterization
  • Show More (4)

News & Updates

Agreement to license and commercialize ophthalmology biosimilars in the US with a partner taking commercial responsibility upon transition of rights.

Received ISO 37301 certification underscoring commitment to compliance management and organizational governance.

Entered global collaboration to co-develop bispecific and dual-payload ADC assets and acquired a license for a TOP1i payload for ADC development.

Published Third Quarter 2025 US Biosimilar Market Report analyzing approvals, launches, pricing trends and policy impacts such as the MFN policy.

History of regulatory approvals and launches for multiple biosimilars across FDA, EMA, MFDS, MHRA and ANVISA since company establishment in 2012.

Commitment to renewable energy (RE100) and implementation of energy-efficiency and environmental management systems.


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