Pathway of Celltrion towards Progress and Innovation
2018 Prepare for sustainable future
Celltrion successfully commercialized its second and third biosimilars, TRUXIMA and HERZUMA in 2018. TRUXIMA, which was launched in April 2017, is increasing its market share in the European market faster than REMSIMA. HERZUMA was also approved by EMA in February 2018 and launched in certain part of European countries.
In addition, Celltrion is accelerating efforts to secure new driving force for continuous growth, starting with the global clinical trials of biosimilar CT-P16 and CT-P17 being developed.
- Application for approval of
RemsimaSC is submitted in the EMA
Herzuma is approved by US (FDA)
- Truxima is approved by US (FDA)
- Begins clinical trial phase 3 of CT-P16
Begins clinical trial phase 1ㆍ3 of CT-P17
- Launches Bio CDMO business
- Herzuma is approved by Europe (EMA)
Lists on KOSPI
2017 Running on the path of full-swing growth
In 2017, Celltrion began to make inroads into the global markets with its second and third biosimilars, TRUXIMA and HERZUMA. The company is now selling the Truxima, first biosimilar mAb in oncology approved by EMA in 2017 in various European countries. In addition, the anticancer drug biosimilar HERZUMA receives positive opinion from EMA's CHMP in December 2017. Celltrion commits to provide more patients greater access to treatment through the ever-growing REMSIMA in global markets and its follow-up products and to promote the human welfare.
- Decision to transfer to KOSPI
- Begins clinical trial phase 1 of CT-P16
- Truxima is approved by Europe (EMA)
2016 Opens a new path as a global leading biologics company
In 2016, Celltrion received marketing authorization for Remsima in the U.S. which occupies half of the antibody biologics market in the world. Remsima, as the first approved biosimilar monoclonal antibodies (mAbs), has become the first mover in the US market, and is expected to have a priceless effect for attaining massive market domination. Domestically, Remsima possesses a total sales volume around 1 trillion KRW and it is expected to be the first single pharmaceutical item to reach sales in trillions of KRW with a total turnover of 20 trillion KRW of the 90 publicly traded pharmaceutical companies. Growth potential of Celltrion is perceived as the birth of new growth engine and an anchor company to lead the future of Korean economy and industry following the manufacturing industries of Korea such as heavy industry, automobile and semiconductor industry.
- Begins clinical trial phase 2b of CT-P27
- Remsima begins sales in US
Truxima is approved by Korea (MFDS)
- Begins global clinical trial phase 1 and 3 of CT-P13 SC (Remsima SC)
- Decision to expand Plant 1(50,000L) and build Plant 3
- Remsima is approved by US (FDA)
2015 Unleashes great ambition towards the future
The world’s first biosimilar mAb Remsima of Celltrion begins sales in Europe. Remsima has topped 60,000 cumulative prescribed patients within 9 months of selling in major European countries and showing rapid growth, engulfing 20% of the original pharmaceutical market.
Celltrion is expected to give new opportunities to patients around the world, who had difficulty in treating their disease due to financial constraints, by replacing the expensive biologics with biosimilars.
- Plant 1 and Plant 2 receive approval from the FDA of U.S. on all cGMP manufacturing facilities
- Remsima begins sales in Europe (Total of 12 countries including Germany, France, UK, Italy)
2014 Sets a new milestone
Herzuma, second to be approved in the world by MFDS, holds greater meaning because it targets cancer. Anti-cancer biosimilars are more difficult to develop than biosimilars for other diseases. If Celltrion succeeds in the development anticancer biosimilars can finally be inexpensively supplied, and opportunities to save numerous lives will be open
The development of Herzuma is evaluated to have established a new milestone in the history of biosimilar development and naminghelped mark-Celltrion in the history of biosimilar development
- Begins clinical trial phase 2a of CT-P27
- Herzuma is approved by Korea (MFDS) and Canada (Health Canada)
2013 Takes a bold leap towards the whole wide world
Celltrion obtained a product license as the world’s first biosimilar mAb (Remsima) by European Medicines Agency(EMA), that had been longed for for 11 years, and started a year of fulfilling sales through global marketing over the entire world.
- Completes clinical trial phase 1 of CT-P27
- Remsima is approved by Europe (EMA)
- Begins global clinical trial of CT-P27
2012 Signals opening of a new market
Celltrion came into the national market by obtaining product approval from the MFDS of the monoclonal antibody biosimilar Remsima that completed global clinical trials.
The approval of Remsima was the initiation signaling the opening of the monoclonal antibody biosimilar market and a giant step to grow into a leading company in the global biosimilar market.
- Remsima is approved by Korea (MFDS)
2011 Ascertain the possibility of barriers
Remsima and Herzuma have successfully completed global clinical trials. It was a proud achievement that every employee at Celltrion created in unison through overcoming all challenges imposed by the first ever global clinical trials.
- Completes clinical trial of Herzuma
- Begins global clinical trial of Truxima
Completes clinical trial of Remsima
- Mechanical completion of Plant 2(90,000L)
2010 Maintains the best competitiveness
Celltrion was recognized for the breakthrough in biosimilar development by international investors (Temasek, a Singapore sovereign wealth fund) and attracted an investment of 200 billion KRW for global clinical trials and construction of the second plant at Celltrion.
Celltrion initiated the first large-scale global clinical trial on Remsima and Herzuma when the domestic pharmaceutical industry had no experience at the time. Through this effort, Celltrion accumulated know-hows on international clinical trials and approval procedures. In addition, the second manufacturing plant with 90,000-liter scale capacity was completed, establishing the base for mass production of world-class (mAb) bio pharmaceuticals.
- Attracted large-scale foreign investment (Singapore Temasek Holdings, 208 billion KRW)
- Begins global clinical trial of Remsima
2009 Dreams of higher values
Celltrion established a licensing strategy and began global clinical trials of biosimilar products based on the agreement of the EMA and the licensing regulatory authorities around the world, at a time when international integrated regulations related to biosimilar products did not exist.
Celltrion Healthcare, a subsidiary of Celltrion, set out to find a global sales market for biosimilar products by taking charge of global marketing. During this period, Celltrion empathized with the company mission to contribute to mankind with biosimilar products, and was able to grow with the employees who unsparingly worked diligently.
- Completes building the worldwide biosimilar sales network
- Contract of cooperation development on new drugs for comprehensive influenza treatment antibodies with the US Center for Disease Control (CDC)
- Begins global clinical trials of Herzuma
2008 Triumph over resistance
Celltrion declared to internationally launch its biosimilar business based on accumulated manufacturing and quality control technology and achievement on biosimilar product development. Also, Celltrion was listed on KOSDAQ through an IPO, but the company went through a difficult time during the global financial crisis triggered by US sub-prime mortgages and the financial difficulty drove Celltrion to adjust the construction timeline of the second plant.
- Initial Public Offering(IPO)
2007 Strengthens the base for a leap
Celltrion obtained facility approval by the USFDA as the first Asian animal cell culture pharmaceutical production facility. Subsequently, Celltrion successfully entered the global mAb biologics market through world-class facilities and management capabilities, and was able to reinvest in domestic production development with the revenue earned by consigned production.
- Plant 1 receives cGMP facility approval by the US FDA
2005 Strengthens the foundation for growth
In 2005, Celltrion completed the first production plant equipped with the independently developed technology. Celltrion went on to complete the global standard of manufacturing and quality control system and signed a Contract Manufacturing Organization (CMO) to produce Orencia (rheumarthritis) from BMS.
On one hand, Celltrion could accumulate the know-hows and techniques for producing biologics, and on the other, it could begin refining the product development of biosimilar products by summoning the hope to develop products with Celltrion-specific technology.
- Mechanical completion of Plant 1(50,000L)
- Supply agreement with BMS(Bristol-Myers Squibb)
2002 New challenges and New Legends
Celltrion was founded in 2002 with only 2 passionate researchers. At the time, the mAb biologics market was dominated by foreign multinational companies based on patents. Celltrion created the world’s first business model based on antibody biosimilars in the pharmaceutical market, and set up an aim to overcome the monopoly by the multinational pharmaceutical companies, and to eventually establish a multinational pharmaceutical company with headquarters based in Korea.
- Foundation of CELLTRION