Celltrion Sees Double-Digit Growth In Sales And Profit
Source : 'Generics Bulletin'
Celltrion, Inc.
has credited continued growth for its leading biosimilars, including increased uptake of Truxima (rituximab) in the US and the expansion of indications for its subcutaneous Remsima SC (infliximab) in Europe, for a significant rise in sales and profits in 2020.
Moreover, after recently receiving a pan-European marketing authorization for its Yuflyma (adalimumab) high-concentration biosimilar rival to Humira, Celltrion said that it expected a continued expansion of its portfolio to be led by increased sales of biosimilars, including its new supply of Yuflyma.
Celltrion received the global first marketing authorization for a 100mg/ml adalimumab biosimilar in February , following a positive opinion for the CT-P17 candidate granted by the European Medicines Agency’s Committee for Medicinal Products for Human Use late last year.
The Korean company reported a 30.3% jump in sales to KRW499bn ($441m) in the fourth quarter of 2020, helping to take its annual total up by almost two-thirds – 63.9% – to KRW1.85trn. Celltrion attributed the growth to “the continued performance of major products, despite the COVID-19 situation.”
However, on a consecutive quarterly basis the company sales saw a slight drop of 9.1% in the fourth quarter, compared to Q3. “Despite the decline in sales compared to last quarter, supply of Yuflyma expanded the product portfolio,” said Celltrion.
The company’s operating profit increased by a significant 44.2% to KRW164.7bn in the fourth quarter, with Celltrion attributing the growth to increased sales of its core products. Full-year profit increased by 88.3% to KRW712.1bn, “driven by improved production efficiency and sales growth.”
In particular, Celltrion pointed to efforts to improve the operational efficiency of of its Plant I facility. Meanwhile, Celltrion’s newly established Plant III was being established to achieve stable capacity for upcoming product lines. Completion and validation is scheduled for mid-2024.
Talking about its biosimilar development strategy, Celltrion said that it planned to acquire more than one product approval annually by 2030, “with most items entering the market as first-mover.”
The company saw stable EU market shares maintained for its Remsima version of infliximab (52.8%), its Truxima biosimilar rituximab (38.0%) and its Herzuma trastuzumab product (15.9%), while in the US Inflectra (infliximab) held a share of 11.8% and Truxima – sold through an alliance with Teva – captured 19.8% of the market.
Meanwhile, Celltrion’s innovative Remsima SC subcutaneous infliximab biosimilar captured material market share among inflammatory bowel disease patients in the EU5 countries, including the UK, according to a newly-released report sampling nearly 250 EU5 gastroenterologists in November and December last year.
The company said that it plans to expand the sales area of Remsima SC, as it has obtained an Australian marketing authorization for rheumatoid arthritis and IBD indications in November 2020. Celltrion also obtained a Canadian marketing authorization for the RA indication in January 2021. And the company also plan to launch the product in additional European countries.
Furthermore, Celltrion said it expected the COVID-19 situation to bolster the increase of switch rate from Remsima IV to Remsima SC in IBD patients. And Celltrion said that experience with Remsima IV had helped Remsima SC to rank fifth in the assessment of familiarity of gastroenterologists in the treatment of UC and CD.
Meanwhile, Celltrion’s anti-COVID-19 monoclonal antibody CT-P59, Regkirona (regdanvimab), has now received domestic and global approval status and obtained conditional marketing authorization from Korea’s Ministry of Food and Drug Safety in early February.
Furthermore, the company announced that additional global approvals, including in the US and the EU, are scheduled to proceed. Celltrion said that for Regkirona, the company is “aiming to obtain an emergency use authorization from FDA and conditional marketing authorization from the EMA in the first half of 2021.”
Celltrion noted that so far Regkirona has completed domestic production for 100,000 patients. The company is working on a production plan for 1.5 million to 3 million patients depending on demand. The company has prioritised production due to the “urgency and importance” of the pandemic.
Celltrion said that Regkirona would be supplied at a “competitive price” compared to other antibody treatments.
According to Celltrion, after studying the treatment’s response to the COVID-19 variants, Regkirona was confirmed to have a “strong neutralizing ability” in the UK variant, while its antibody candidate No. 32 has a “neutralizing ability in both UK and South Africa variants.” The company said that the development of antibody cocktail (Regkirona + candidate) is also in progress for potential variants.
By Akriti Seth