Our story

Celltrion USA exists to help medicine keep pace with real life. As the North American affiliate of Celltrion, Inc.—a global biopharmaceutical innovator with more than 20 years of experience—we’re focused on building new possibilities in biologic care: greater access, more choices, and higher standards for patients and providers.

Founded in 2002, Celltrion has redefined access to high-quality therapies, launching the world’s first monoclonal antibody biosimilar and now reaching patients in 110+ countries. With US headquarters in New Jersey, we combine global research and development, deep manufacturing expertise, and regulatory excellence to build more possibilities for US patients.

2002
2005
2007
2008
2011
2012
2013
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
2002
Celltrion founded

Feb. 2002

Celltrion founded

2005
Supply agreement with Bristol-Myers Squibb

Jun. 2005

Supply agreement with Bristol-Myers Squibb

Jul. 2005

Plant 1 (50,000L) completed

2007
Plant 1 receives cGMP facility approval by US FDA

Dec. 2007

Plant 1 receives cGMP facility approval by US FDA

2008
Initial Public Offering (IPO)

Aug. 2008

Initial Public Offering (IPO)

2011
Plant 2 (90,000L) completed

Oct. 2011

Plant 2 (90,000L) completed

2012
Remsima receives approval by Korea MFDS

Jul. 2012

Remsima receives approval by Korea MFDS

2013
Remsima receives approval by Europe MFDS

Jul. 2013

Remsima receives approval by Europe MFDS

2015
Plant 1 & 2 receive approval by US FDA on all cGMP manufacturing facilities

Jul. 2015

Plant 1 & 2 receive approval by US FDA on all cGMP manufacturing facilities

2016
Remsima receives approval by US FDA

Apr. 2016

Remsima receives approval by US FDA

2017
Truxima receives approval by Europe EMA

Feb. 2017

Truxima receives approval by Europe EMA

2018
Temixys receives approval by US FDA

Nov. 2018

Temixys receives approval by US FDA

Dec. 2018

Herzuma receives approval by US FDA

2019
Expansion of Plant 1 (additional 50,000L) completed

May. 2019

Expansion of Plant 1 (additional 50,000L) completed

Nov. 2019

Remsima SC receives approval by Europe EMA

2020
Reached KRW 1 trillion in annual sales

Feb. 2020

Reached KRW 1 trillion in annual sales

Aug. 2020

Acquired Primary Care product assets for Asia Pacific markets from Takeda Ltd.

2021
Yuflyma receives approval by Europe EMA

Feb. 2021

Yuflyma receives approval by Europe EMA

Nov. 2021

Regkirona receives approval by Europe EMA

2022
Vegzelma receives approval by Europe EMA

Aug. 2022

Vegzelma receives approval by Europe EMA

Sep. 2022

Vegzelma receives approval by US FDA

2023
Yuflyma receives approval by US FDA

May. 2023

Yuflyma receives approval by US FDA

Oct. 2023

Zymfentra (Remsima SC) received FDA approval as novel therapeutics

Dec. 2023

Celltrion Inc. & Celltrion Healthcare Co., Ltd. merger completed

2024
Steqeyma FDA Approved

Dec. 2024

Steqeyma FDA Approved

2025
Avtozma receives approval by US FDA

Jan. 2025

Avtozma receives approval by US FDA

Mar. 2025

Omlyclo receives approval by US FDA

Oct. 2025

Eydenzelt receives approval by US FDA

2026
Acquisition of the Branchburg Manufacturing Facility (66,000L)

Jan. 2026

Acquisition of the Branchburg Manufacturing Facility (66,000L)

Our collective global impact

3,153 EMPLOYEES GLOBALLY

20+

YEARS OF
MANUFACTURING
EXCELLENCE

12

MEDICINES
APPROVED GLOBALLY

32%

OF STAFF FOCUSED
ON R&D

10+

TREATMENTS IN
CLINICAL STAGES

12

MANUFACTURING
SITES WORLDWIDE

46+

SUBSIDIARIES
WORLDWIDE

952K+

PATIENTS REACHED
IN A SINGLE YEAR

FULLY INTEGRATED BIOPHARMACEUTICAL LEADER

316,000L

TOTAL PRODUCTION
CAPACITY

>$300M

INVESTMENT
IN R&D TO DATE

99%

MANUFACTURING
SUCCESS RATE

Meet our leadership

Jungjin Seo

Chairman/Founder, Celltrion Inc

Joonserk Seo

Chair of Board, Celltrion USA

BonJoong Kim

CEO, Celltrion USA

From our founder

Upon founding Celltrion in 2002, my vision was simple yet ambitious: to challenge convention and create a company that could improve lives by leading the way in biopharmaceutical innovation. With just $40,000 in capital, we took our first steps toward an idea that Korea could guide the world in biosimilar development. And this idea has since become reality.

Celltrion’s history is one of continuous innovation and perseverance. From developing Remsima, the world’s first monoclonal antibody biosimilar, to launching multiple breakthrough biopharmaceuticals, we have proven vision and determination can overcome even the humblest beginnings. With a well-established global presence, Celltrion continues its vision to transform global healthcare through novel drug development and providing the best care for all, creating new possibilities for patients and future generations.

I have always believed in the importance of onsite leadership. It is critical to meet partners face-to-face, listen directly to patients and healthcare professionals, and be on the ground to expand our global presence. That onsite leadership remains part of who we are today: a company driven by action and integrity.

In 2021, I was honored to be the first Korean entrepreneur to receive the EY World Entrepreneur of the Year award. Yet this recognition belongs not to me alone, but to everyone who believes in our vision.

As we move forward, my promise remains the same: to continue leading with purpose, pushing boundaries, and creating a future where advanced medicines are accessible to all.

Jungjin Seo
Founder & Chairman, Celltrion