Celltrion Healthcare

What Celltrion Healthcare does

Celltrion Healthcare Co., Ltd. is a South Korea-based, specialty pharmaceutical company focused on the global commercialization of biosimilar monoclonal antibodies, headquartered in Incheon and operating in 110+ countries through a network of 30+ distribution partners plus a direct US subsidiary (Celltrion USA, established 2018 in New Jersey). Its core portfolio consists of biosimilars to major reference biologics: Remsima (infliximab, EMA 2013, FDA 2016 — the world's first monoclonal antibody biosimilar), Remsima SC and ZYMFENTRA (subcutaneous infliximab), Truxima (rituximab), Herzuma (trastuzumab), Yuflyma (high-concentration citrate-free adalimumab), Vegzelma (bevacizumab), and Regkirona (regdanvimab), spanning autoimmune diseases (rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis) and oncology (breast, gastric, colorectal, lung, lymphoma, leukemia). Products are manufactured at mammalian cell culture facilities compliant with US FDA cGMP and EU GMP guidelines.

The company monetizes primarily through one-time biosimilar product sales plus licensing and distribution royalties to global partners, with pricing negotiated privately through healthcare systems, insurers, and government reimbursement programs. Go-to-market combines direct sales in the US (via Celltrion USA and PBM/MBM contracts with partners such as Ventegra covering ~13 million members) with channel-partner distribution in Europe, Asia-Pacific, Latin America, and the Middle East/Africa. In October 2023, shareholders approved an absorption-type merger into parent company Celltrion Inc. (effective 28 December 2023), dissolving Celltrion Healthcare as a separate legal entity while continuing its commercial operations under the parent. The combined Celltrion group reported record revenue exceeding $3 billion and operating profit of $880 million in 2025, with Q1 2026 net income up 222.9% year-over-year.

Name

Celltrion Healthcare

Legal name

Celltrion Healthcare Co., Ltd.

Website

https://celltrionhealthcare.com

Company type

Private

Founded year

2012

Operating status

Acquired

Headcount range

1–10 employees

Short description

Celltrion Healthcare is a South Korea-based biosimilar pharmaceutical company that develops, manufactures, and globally commercializes monoclonal antibody biosimilars including infliximab, rituximab, trastuzumab, adalimumab, and bevacizumab for autoimmune and oncology patients in 110+ countries.

Ownership category

akta.pro rank

Product category

Biosimilar Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Anti-TNF Biosimilars (HLAIAFAE)

akta.pro secondary industries

Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Autoimmune & Rheumatology Biosimilars (HLAAAHAI)

Keywords

• Biosimilar pharmaceuticals
• Monoclonal antibody drugs
• Biologic medicines
• Autoimmune disease treatments
• Oncology biosimilars

Headquarters

HQ city

Incheon

HQ country

South Korea

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Technology or R&D, Supply Chain, Marketing or Sales, Personnel, Infrastructure

Revenue model

1. Biosimilar Product Sales: Revenue generated from global sales of biosimilar pharmaceutical products including Remsima, Truxima, Herzuma, Yuflyma, Vegzelma, and Regkirona across autoimmune and oncology therapeutic areas.
2. Licensing and Distribution Rights: Revenue from licensing biosimilar products to global partners and distributors in various regional markets.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels9 records

Core offering

Celltrion Healthcare develops, manufactures, and globally commercializes biosimilar monoclonal antibody pharmaceuticals for autoimmune diseases (rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis) and oncology indications (breast, gastric, colorectal, lung cancers). The portfolio includes both intravenous and innovative subcutaneous formulations of infliximab, rituximab, trastuzumab, adalimumab, and bevacizumab biosimilars distributed across 110+ countries.

Product overview

Celltrion Healthcare is a global biologics company specializing in biosimilar pharmaceuticals. The company offers a portfolio of monoclonal antibody biosimilars including Remsima® (infliximab), Truxima® (rituximab), Herzuma® (trastuzumab), Remsima®SC (subcutaneous infliximab), Yuflyma® (adalimumab), Vegzelma® (bevacizumab), RegkironaTM (regdanvimab), and ZYMFENTRA™ (subcutaneous infliximab for IBD). These products treat autoimmune diseases (rheumatoid arthritis, Crohn's disease, ulcerative colitis) and cancers (breast cancer, lymphoma, colorectal cancer, lung cancer). The portfolio ranges from intravenous formulations to innovative subcutaneous delivery options, with global reach across 110+ countries.

Differentiator

Problem solved

Functional benefit

Brands

• Remsima®: World's first monoclonal antibody biosimilar infliximab; approved by EMA (2013) and FDA (2016). Used for rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, psoriatic arthritis, and psoriasis.
• Truxima®
• Herzuma®
• Remsima®SC
• Yuflyma®
• Regkirona™
• Vegzelma®
• ZYMFENTRA™

Products and services

• Remsima® (infliximab biosimilar / CT-P13) World's first monoclonal antibody biosimilar of infliximab (anti-TNFα). Approved by EMA (2013) and FDA (2016). Treats 8 autoimmune diseases including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
• Truxima® (rituximab biosimilar) Biosimilar rituximab (anti-CD20 monoclonal antibody). Approved by EMA (2017) and FDA (2018). Treats Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, and Rheumatoid Arthritis.
• Herzuma® (trastuzumab biosimilar) Biosimilar trastuzumab (anti-HER2 monoclonal antibody). Approved by EMA (2018) and FDA (2018). Treats HER2-positive metastatic breast cancer, early breast cancer, and metastatic gastric cancer.
• Remsima®SC (subcutaneous infliximab) World's first subcutaneous formulation of infliximab biosimilar. Approved by EMA (2019). Provides at-home treatment option for RA, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
• Yuflyma® (adalimumab-aaty biosimilar / CT-P17) High-concentration (100mg/mL), citrate-free adalimumab biosimilar (anti-TNFα). First high-concentration adalimumab biosimilar with EU Commission approval. FDA approved for 8 indications including RA, JIA, PsA, AS, CD, UC, plaque psoriasis, and hidradenitis suppurativa.
• Regkirona™ (regdanvimab) Monoclonal antibody therapeutic for COVID-19 treatment.
• Vegzelma® (bevacizumab-adcd biosimilar) Biosimilar bevacizumab (anti-VEGF monoclonal antibody). FDA approved (2022) for 6 cancer types: metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian/fallopian tube/peritoneal cancer.
• ZYMFENTRA™ (infliximab-dyyb, subcutaneous) First and only FDA-approved subcutaneous formulation of infliximab for maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. Blocks TNF-alpha to reduce immune system attacks on healthy tissues.

Quantifiable outcome

• Remsima holds 55% market share in Europe (2022)
• +3 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered core.

• VentebracoreChannel Partner/ Reseller/ Distributor · 11 December 2023Ventegra placed VEGZELMA (bevacizumab-adcd) on its commercial formulary as a preferred brand. Ventegra's formulary program serves more than 400 clients and 13 million members/patients in the US, marking a significant step for oncology biosimilar access.
• CarePartners Specialty PharmacycoreChannel Partner/ Reseller/ Distributor · 26 October 2023Celltrion USA announced distribution and incorporation of YUFLYMA to CarePartners Specialty Pharmacy Cost Savings Programs. The treatment became available through CarePartners making Yuflyma accessible to over 10 million plan members, offering the lowest net cost high-concentration Humira biosimilar.
• VentegracoreChannel Partner/ Reseller/ Distributor · 5 September 2023Celltrion USA signed contract with Ventegra, a Medical Benefits Manager (MBM), to include Yuflyma (adalimumab-aaty) as a preferred drug on its formulary. By inclusion in Ventegra's formularies, Celltrion secured access for approximately 3.6% of the US population and 13 million members/patients through its commercial formulary covering both public and private insurance markets.
• Global Distribution PartnerscoreChannel Partner/ Reseller/ DistributorCelltrion Healthcare has established partnerships with more than 30 global pharmaceutical distribution companies enabling sales in 110+ countries worldwide. Partners include regional distributors across Europe, Asia, Latin America, Africa, and Oceania.

Scale indicators9 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Organon & Co. Organon, spun off from Merck in 2021, holds a women's health and biosimilars portfolio including the trastuzumab biosimilar Aybintio/SB-960 (partnered with Samsung Bioepis) and other biosimilars. While narrower in scope, Organon competes in similar mAb biosimilar categories targeting payers and provider channels in the U.S. and Europe.
• Biocon Biologics: Biocon Biologics (India) is a major pure-play biosimilar developer with monoclonal antibody biosimilars of trastuzumab (Ogivri), bevacizumab (Abevmy), pegfilgrastim, and rituximab referencing the same reference biologics as Celltrion's Herzuma/Vegzelma portfolio, often competing in the U.S., EU, and emerging markets.
• Pfizer: Pfizer commercializes a broad biosimilars portfolio (Nivestym, Retacrit, Zirabev, Ruxience, Trazimera) following its Hospira/Upjohn acquisitions. Pfizer's oncology and supportive-care biosimilars overlap directly with Celltrion's Truxima, Herzuma, and Vegzelma in U.S. and European channels.
• Amgen: Amgen is both an innovator biologics manufacturer and a major biosimilars player, with Amjevita (adalimumab biosimilar) and Kanjinti (trastuzumab). Amgen directly competes with Celltrion's Yuflyma and Herzuma in the U.S. and European markets.
• Sandoz: Sandoz (spun off from Novartis in 2023) is the world's largest biosimilars company with a broad portfolio across oncology, immunology, and supportive care. Both Celltrion and Sandoz compete head-to-head in infliximab (Remsima vs. Zessly/Inflectra partner), rituximab, pegfilgrastim, and adalimumab biosimilar markets globally.
• Samsung Bioepis: Samsung Bioepis is a South Korean biosimilar developer — a direct regional rival — with biosimilars of etanercept (Benepali/Brenzys), infliximab (Renflexis/Flixabi), adalimumab (Hadlima/Imraldi), trastuzumab (Ontruzant), and bevacizumab (Aybintio). Both companies share Korean roots, similar platform technology, and overlapping global commercial partners (Biogen/Merck).

Regional players

• Fresenius Kabi: Fresenius Kabi is a German-based pharmaceutical and medical device company with a growing biosimilars portfolio (Idacio/adalimumab, Kromeya/infliximab). It competes with Celltrion particularly in European hospital tender markets for infliximab and other mAb biosimilars.

Broad incumbents

• Teva Pharmaceutical Industries: Teva has a portfolio of biosimilars (e.g., Truxima competitor markets, proposed adalimumab biosimilar). Although primarily generics-focused, Teva's biosimilar pipeline and global commercial reach overlap with Celltrion's distribution network and therapeutic-area focus.
• Viatris (Mylan biosimilars): Viatris (formed via Mylan-Upjohn combination) markets infliximab biosimilar (in partnership with Biocon), pegfilgrastim biosimilar (Fulphila), and etanercept biosimilar. Viatris competes with Celltrion in immunology and supportive-care biosimilar categories globally through its large generics/biosimilars infrastructure.

Emerging players

• Coherus BioSciences: Coherus is a U.S.-based biosimilars company with Udenyca (pegfilgrastim) and Yusimry/Hyrimoz (adalimumab). It represents the same U.S. focused, payer/channel-driven commercial model Celltrion is building with Celltrion USA, and competes in the same adalimumab/U.S. negotiation dynamic that Yuflyma faces.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

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Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Celltrion Healthcare