[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 9th that its consolidated sales for the third quarter of this year reached 645.6 billion KRW, marking a 60.6% increase compared to the same period last year. Operating profit was tentatively estimated at 213.8 billion KRW, up 28.1% during the same period.
In the biosimilar business, the increase in supply of Remsima, which continues its global growth trend, was identified as a major factor driving sales expansion. Along with this, sales of chemical drugs also increased, centered on products whose asset rights were acquired from Takeda Pharmaceutical, showing balanced growth in both biopharmaceuticals and chemical pharmaceuticals.
Stable Market Share of Major Biosimilars in Europe and the U.S.
Celltrion’s major biosimilar product lines?Remsima, Truxima, and Herzuma?maintain stable market shares in the European autoimmune disease treatment and anticancer drug markets. According to pharmaceutical market research firm IQVIA and Celltrion Healthcare, in the second quarter of this year, Remsima recorded a 53.6% market share, Truxima 23.6%, and Herzuma 12.7% in the European market. According to medical information provider Symphony Health, Remsima (sold under the brand name Inflectra) sold through Pfizer in the U.S. recorded a 31.7% market share in the third quarter of this year, up 10.5 percentage points compared to the same period last year. Truxima, sold through Teva, also recorded a 27.6% market share, up 3.8 percentage points year-over-year.
The growth of RemsimaSC is also noteworthy. As the shift from intravenous (IV) formulation to subcutaneous (SC) formulation accelerates, RemsimaSC achieved a 27% market share in Germany and 16% in France, recording a 10.7% market share in the infliximab market across the five major European countries. Celltrion expects that when RemsimaSC is launched in the U.S., riding on its growth momentum in Europe, both the IV formulation Remsima and the SC formulation RemsimaSC will demonstrate synergistic growth, similar to the European market.
Unlike in Europe, RemsimaSC is scheduled to be launched as a new drug in the U.S., and it is expected to show greater market penetration through patent protection. Celltrion also plans to solidify its leading position in the inflammatory bowel disease (IBD) indication market by establishing the world’s first high-concentration Humira biosimilar, Uplyma, in the European market.
Smooth Progress of Follow-up Biosimilar Clinical Trials... Securing New Growth Engines through New Drug Development
Celltrion has completed development of six biosimilar products for autoimmune disease treatments and anticancer antibodies and is accelerating portfolio expansion by conducting Phase 3 clinical trials for five follow-up biosimilars. Since August, it has sequentially obtained marketing approvals for the Avastin biosimilar Vegzelma from regulatory agencies in Europe, the UK, Japan, the U.S., and South Korea. Celltrion Healthcare, responsible for overseas sales of Vegzelma, recently launched it in the UK and Germany. Additionally, five biosimilar products?Stelara biosimilar CT-P43, Actemra biosimilar CT-P47, Eylea biosimilar CT-P42, Xolair biosimilar CT-P39, and Prolia biosimilar CT-P41?are currently undergoing global Phase 3 clinical trials.
Celltrion is also laying the groundwork for new drug development. It is conducting equity investments, technology acquisitions, and joint development in areas such as antibody-drug conjugates (ADC) and bispecific antibodies. Following an equity investment in the UK ADC developer 'Exsuda Therapeutics,' Celltrion signed a license option agreement for the ADC linker-payload platform technology with domestic biotech company 'Pinobio,' accelerating ADC anticancer drug development. Last month, Celltrion secured rights to utilize Pinobio’s linker-payload platform for up to 15 targets and established a long-term partnership through equity investment and joint research agreements. Earlier in September, Celltrion also signed a joint development agreement with U.S. biotech 'ABPro' for the bispecific antibody therapy ABP102 targeting HER2-positive breast cancer, strengthening its anticancer drug portfolio.
A Celltrion official stated, "In this quarter, both biopharmaceuticals and chemical pharmaceuticals showed balanced growth in the global market, resulting in significant increases in sales and operating profit compared to the same period last year. We will continue to proceed smoothly with clinical trials and development of follow-up biosimilars and do our best to secure new growth engines and develop new drugs through cooperation with various domestic and international companies."
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