President Moon speaks about the bio success myth Celltrion
Posted on July 1, 2019 15:40
Modified on July 1, 2019 15:54
The start-up company that began the business with 50 million KRW 10 years ago, reached 1 billion won in annual sales ... from Biosimilar to new drugs, U-health
It has become an issue that President Moon mentioned Celltrion’s success story as he announces the innovation strategy to nurture the bio-health up to the level of global standard by investing more than 4 trillion won annually.
In the Biohealth National Vision Proclamation Ceremony of May 22nd, President Moon gave the example of Celltrion that is winning in the biosimilar market after starting up the business with its 50 million won 10 years ago and announced that the government will select biohealth sector as one of the three strategic new industries and expressed the intention to support them.
Celltrion's leading biosimilar ‘Remsima' is the first biosimilar to be approved by the European Commission (EC) as antibody biosimilar in 2013 for the first time in the world, and has been approved for the sales in 80 countries including the EU, USA, Canada. It is the first biosimilar to exceed the market share of original drugs in Europe, and its market share in Europe is about 57% by the end of 2018.
Subsequently, the company developed a new type of injectable drug, Remsima SC, and submitted an application for approval to the European Medicines Agency (EMA) in November 2018 and is waiting for the final approval. The company has completed the application for approval (IND) that is required for the approval in the US and plans to launch Phase 3 clinical trials this year.
TRUXIMA has begun it sales in Europe since the second quarter of 2017 and captured the market share of 36% in the European market as of the end of 2018 and HERZUMA has recorded the market share of 10% in Europe since the second half of 2018. Both Truxima and Herzuma have been finally approved from the US Food and Drug Administration (FDA) in November and December of 2018 respectively and they are now in the preparation stage for the launch of sales.
In the middle of May, Jung Jin Seo, the Chairman of Celltrion Group, announced mid to long-term business plan of Celltrion Group and said that the company plans to invest 40 trillion won by 2030.
According to the 'Celltrion Group Vision 2030', more than 20 second-generation biosimilars including immunosuppressive anti-cancer drugs will be developed, and 10 new drugs will be developed, focusing on immunotherapeutic drugs. In addition, the company plans to expand the facilities that are capable of producing 1,500 batches (1 million liters) of the raw material for the biopharmaceuticals per year, and to secure the world's largest production capacity by establishing the finished drug production environment that can produce 100 million vials annually.
President Moon said, "Domestic companies accounted for two-thirds of the global biosimilar market last year, and the quantity of biopharmaceutical production is the second largest in the world. In the past year, we exported $ 4.8 billion of new drug technology to overseas markets and the exportation of the pharmaceutical products and medical devices have increased 20% annually that is equivalent to $14.4 billion,” and he went on to say that "The government is trying to make the world market share of pharmaceuticals and medical devices to be 6%, to record $ 50 billion exportation, and to nurture them as 5 major export industries by 2030."
By Park Do-Young