Celltrion Pharm, Inc.


Celltrion is a leading biopharmaceutical company dedicated to researching, developing, manufacturing, marketing, and selling innovative therapeutics to improve people's lives worldwide. With a strong focus on biosimilars and novel drugs, Celltrion aims to expand patient access to high-quality biologics and push the boundaries of scientific innovation.

Industries

biotechnology
health-care
manufacturing

Nr. of Employees

Very Large (1000+)

Celltrion Pharm, Inc.

23, Academy-ro, Yeonsu-gu, Incheon, Republic of Korea


Patents

Expression cassette for production of high-expression and high-functionality target protein and use thereof

US-12188036-B2

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Dosing regimen for treating influenza virus diseases

US-12157764-B2

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Stable liquid pharmaceutical formulation of anti-influenza virus antibody

US-12065482-B2

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Stable liquid formula comprising anti-TNFa antibody, acetate buffer, and glycine

US-11986523-B2

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Stable liquid pharmaceutical preparation

US-11951207-B2

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Stable liquid pharmaceutical preparation

US-11730698-B2

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Products

Subcutaneous infliximab maintenance formulation

A subcutaneous fixed‑dose formulation of an infliximab‑class monoclonal antibody developed to enable at‑home self‑administration while providing systemic exposure comparable to intravenous induction.

Monoclonal antibody biosimilar portfolio

A range of clinically developed and commercially marketed monoclonal antibody biosimilars addressing therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology for global distribution.

Denosumab‑class biosimilar products (U.S. approvals)

Biosimilar therapeutics referencing denosumab approved for indications such as osteoporosis and prevention of skeletal‑related events, supported by U.S. regulatory approvals and commercial launch activities.

High‑concentration adalimumab biosimilar with interchangeability designation

A high‑concentration, low‑volume adalimumab biosimilar formulation that has received regulatory interchangeability designation for multiple delivery presentations, enabling substitution where permitted.

Ustekinumab‑class biosimilar with expanded presentation approvals

A biosimilar to ustekinumab with regulatory approvals for multiple dosage forms and strengths, including presentations that expand pediatric dosing flexibility.


Services

Contract development and manufacturing for biologics covering candidate screening, cell line development, upstream and downstream process development, analytical method development, formulation, clinical/non‑clinical material production, regulatory dossier support and commercial manufacturing.

Services to support commercial launch and market access including multi‑region distribution operations, specialty pharmacy partnerships, payer and formulary engagement, and launch planning.

Design and administration of patient support programs and affordability initiatives to improve treatment access after product launch.

Expertise Areas

  • Clinical trial management and multi‑region study operations
  • Biosimilar development and regulatory strategy including interchangeability
  • Biologics manufacturing and commercial scale‑up
  • Contract development and manufacturing (CDMO) for biologics
  • Show More (7)

Key Technologies

  • Antibody‑drug conjugate (ADC) platforms
  • Multispecific antibody engineering
  • Subcutaneous biologic formulation technologies (high‑concentration, low‑volume)
  • mRNA therapeutic platforms
  • Show More (7)

News & Updates

Celltrion announced its innovative drug development strategy, including plans to submit 13 IND applications by 2028, focusing on ADCs and multispecific antibodies.

A post-hoc analysis shows dose escalation of CT-P13 SC demonstrates clinical efficacy over 102 weeks with a safety profile comparable to non-escalation.

Two-year results demonstrate long-term benefits and safety of CT-P13 SC in Crohn's disease and ulcerative colitis.

Omlyclo® is approved for allergic asthma, CSU, and CRSwNP, with clinical evidence showing comparable efficacy and safety to Xolair®.

U.S. FDA approves Celltrion's AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA®

Celltrion's biosimilar AVTOZMA® received FDA approval, expanding its portfolio of biosimilars.

Celltrion's Zymfentra demonstrates long-term efficacy and safety in Crohn's and UC

Two-year data shows Zymfentra's sustained efficacy and safety profile in IBD treatment.

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