Celltrion USA

What Celltrion USA does

Celltrion USA, Inc. is the U.S. biopharmaceutical subsidiary of Celltrion, Inc. (Korean Stock Exchange: 068270.KS), established in 2018 and headquartered at 1 Evertrust Plaza, Jersey City, NJ. The company commercializes a portfolio of twelve FDA-approved biosimilar monoclonal antibodies and one novel biologic (ZYMFENTRA, the first subcutaneous infliximab) across five therapeutic areas: immunology, oncology, hematology, endocrinology, and ophthalmology. Products include INFLECTRA, TRUXIMA, HERZUMA, VEGZELMA, YUFLYMA, AVTOZMA, STEQEYMA, STOBOCLO, OSENVELT, OMLYCLO, and EYDENZELT, referencing major biologics such as Remicade, Rituxan, Herceptin, Avastin, Humira, Actemra, Stelara, Prolia, Xgeva, Xolair, and Eylea.

The underlying technology is rooted in Celltrion's proprietary mammalian cell culture manufacturing facilities built to FDA CGMP and EU GMP standards, along with a biosimilar development platform credited with launching the world's first monoclonal antibody biosimilar. Celltrion USA distributes these products through standard pharmaceutical channels — specialty pharmacies, healthcare systems, hospital networks — supported by field-based Medical Science Liaisons, an Investigator-Initiated Trials program for medical education, and patient support platforms (Celltrion CONNECT, Celltrion CARES co-pay assistance). Revenue is generated through one-time prescription product sales to U.S. healthcare providers and patients, with pricing negotiated through payors, healthcare systems, and government programs. The customer base spans gastroenterologists, rheumatologists, oncologists, endocrinologists, ophthalmologists, and patients with immune-mediated diseases, cancer, osteoporosis, and retinal conditions.

Name

Celltrion USA

Legal name

Celltrion USA, Inc.

Website

https://celltrionusa.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

251–500 employees

Short description

Celltrion USA is the U.S. subsidiary of Celltrion, Inc., commercializing twelve FDA-approved biosimilar monoclonal antibodies and one novel biologic across immunology, oncology, hematology, endocrinology, and ophthalmology for U.S. healthcare providers and patients.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals (Biosimilars and Novel Biologics)

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE)

akta.pro secondary industry

Specialty Injectable & Infusion Therapies (Cross-therapeutic) (HLAIACAO)

Keywords

• Biosimilar pharmaceuticals
• Monoclonal antibody therapeutics
• Biologic drug products
• Immunology oncology treatments
• Biopharmaceutical distribution

Headquarters

HQ city

Jersey City

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Biopharmaceutical Product Sales: Celltrion USA generates revenue through the sale of FDA-approved biosimilar and novel biologic products to healthcare providers, hospitals, specialty pharmacies, and patients in the United States. Products are distributed through standard pharmaceutical supply channels.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Celltrion USA markets and distributes a portfolio of twelve FDA-approved biosimilar monoclonal antibodies and one novel biologic (ZYMFENTRA) across immunology, oncology, hematology, endocrinology, and ophthalmology therapeutic areas in the United States. Products are sold to healthcare providers, hospitals, and specialty pharmacies in intravenous, subcutaneous, and prefilled syringe formulations for the treatment of immune-mediated diseases, cancers, osteoporosis, ophthalmologic conditions, and allergic diseases.

Product overview

Celltrion USA operates as a biopharmaceutical company offering a diversified portfolio of FDA-approved biosimilar products and one novel biologic. The portfolio spans five therapeutic areas: immunology (INFLECTRA, TRUXIMA, VEGZELMA, YUFLYMA, AVTOZMA, STEQEYMA, ZYMFENTRA), oncology (HERZUMA, VEGZELMA), hematology (TRUXIMA), endocrinology (STOBOCLO, OSENVELT), and ophthalmology (EYDENZELT). The company also offers OMLYCLO for allergic diseases. These products are distributed in the United States through various formulations including intravenous infusion, subcutaneous injection, and prefilled syringes. The portfolio includes both biosimilars referencing established reference products and the novel biologic ZYMFENTRA, which represents an innovative subcutaneous delivery of infliximab.

Differentiator

Problem solved

Functional benefit

Products and services

• INFLECTRA® (infliximab-dyyb) Biosimilar referencing Remicade® (infliximab), a tumor necrosis factor (TNF) inhibitor used for treating autoimmune conditions including rheumatoid arthritis, Crohn's disease, and ulcerative colitis.
• TRUXIMA® (rituximab-abbs) Biosimilar referencing Rituxan® (rituximab), a monoclonal antibody for treating B-cell lymphomas and autoimmune diseases.
• HERZUMA® (trastuzumab-pkrb) Biosimilar referencing Herceptin® (trastuzumab), a monoclonal antibody for treating HER2-positive breast cancer and other HER2-overexpressing cancers.
• VEGZELMA® (bevacizumab-adcd) Biosimilar referencing Avastin® (bevacizumab), an anti-VEGF monoclonal antibody for treating various cancers including colorectal, lung, kidney, and ovarian cancer.
• YUFLYMA® (adalimumab-aaty) High-concentration, citrate-free biosimilar referencing Humira® (adalimumab), a TNF inhibitor for treating rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.
• AVTOZMA® (tocilizumab-anoh) Biosimilar referencing Actemra® (tocilizumab), an interleukin-6 (IL-6) receptor antagonist available in both intravenous and subcutaneous formulations for treating rheumatoid arthritis, giant cell arteritis, juvenile idiopathic arthritis, cytokine release syndrome, and COVID-19.
• STEQEYMA® (ustekinumab-stba) Biosimilar referencing Stelara® (ustekinumab), a human IL-12/23 antagonist for treating plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
• STOBOCLO® (denosumab-bmwo) Biosimilar referencing Prolia® (denosumab), a RANKL inhibitor for treating postmenopausal osteoporosis, male osteoporosis, glucocorticoid-induced osteoporosis, and bone loss from cancer hormone therapy.
• OSENVELT® (denosumab-bmwo) Biosimilar referencing Xgeva® (denosumab), a RANKL inhibitor for preventing skeletal-related events in multiple myeloma and bone metastases, treating giant cell tumor of bone, and hypercalcemia of malignancy.
• OMLYCLO® (omalizumab-igec) First and only FDA-approved anti-IgE antibody biosimilar referencing Xolair® (omalizumab), for treating moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria.
• EYDENZELT® (aflibercept-boav) Biosimilar referencing Eylea® (aflibercept), a VEGF inhibitor for treating neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
• ZYMFENTRA® (infliximab-dyyb) Novel biologic with first-approved subcutaneous administration form of infliximab, used for maintenance treatment of moderately-to-severely active ulcerative colitis and Crohn's disease following IV infliximab treatment.

Quantifiable outcome

• ZYMFENTRA achieved 60.95% clinical remission in ileum-dominant Crohn's disease and 66.95% in colon-dominant Crohn's disease at Week 54 vs placebo
• +2 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Teva Pharmaceutical Industries: Diversified specialty pharma with a biosimilars unit (TRUXIMA in some markets, and partnerships on others); competes with Celltrion USA particularly in immunology and oncology biosimilars.
• Pfizer: Markets biosimilars including INFLECTRA (infliximab) and a portfolio of oncology and immunology biosimilars inherited from Hospira; competes directly with Celltrion USA on multiple molecules and has significantly larger U.S. commercial reach.
• Amgen: Originator of several reference biologics (e.g., Prolia/Xgeva, Enbrel) and a major biosimilar developer (AMJEVITA, PAVBLU); competes with Celltrion USA on both the originator and biosimilar sides with a far larger oncology and inflammation portfolio.

Direct peers

• Biocon Biologics: India-based biosimilar developer with U.S. approvals (e.g., Ogivri, Fulphila) and the acquired Viatris biosimilars business; competes directly with Celltrion USA on trastuzumab, pegfilgrastim, and other oncology/immunology biosimilars.
• Sandoz (Novartis): Global biosimilars leader with a broad U.S.-approved biosimilar portfolio across immunology and oncology; competes head-to-head with Celltrion USA on molecules such as infliximab, rituximab, trastuzumab, and adalimumab, and is the closest direct comparable in biosimilar commercial scale and breadth.
• Coherus BioSciences: U.S.-headquartered biosimilar and immuno-oncology company with UDENYCA (pegfilgrastim) and an ophthalmology biosimilar pipeline; competes with Celltrion USA on biosimilar commercialization and has similar scale and U.S.-centric focus.
• Samsung Bioepis: Joint venture between Samsung Biologics and Biogen, commercializing biosimilars in immunology and oncology (e.g., Imraldi, Renflexis, Ontruzant); directly competes with Celltrion USA across the same molecule set.
• Viatris: Biosimilars-focused player (Hulio, Hulspire, and a partnered pipeline) with deep U.S. commercial and specialty distribution; directly competes with Celltrion USA in immunology and oncology biosimilars.
• Fresenius Kabi: Healthcare company with a growing biosimilars portfolio (MSB11455/IDACIO adalimumab in U.S., and pipeline in oncology); competes with Celltrion USA on adalimumab and other immunology biosimilars and brings hospital-channel strength.
• Alvotech: Iceland-based pure-play biosimilar developer with U.S. FDA approvals (e.g., adalimumab, ustekinumab candidates); competes directly with Celltrion USA on the same high-value immunology molecules.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/celltrionusa

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Celltrion USA