HONG KONG – Celltrion Healthcare Co. Ltd., a South Korean biopharmaceutical corporation, won European Union (EU) marketing approval for Remsima SC for the treatment of rheumatoid arthritis (RA), as a subcutaneous version of Celltrion’s infliximab biosimilar, CT-P13.
The Incheon-based company said that it is the world’s first subcutaneous version of the TNF-alpha-targeting monoclonal antibody. The drug has been approved for the treatment of RA in combination with methotrexate (MTX), in adult patients with active RA when the response to disease-modifying antirheumatic drugs (DMARDs) has been inadequate; and in adult patients with active and progressive disease not formerly treated with MTX or other DMARDs.
EU marketing approval was based on the phase I/III study designed to evaluate pharmacokinetics, efficacy and safety between CT-P13 SC and the intravenous (I.V.) version of CT-P13 in people with active RA. Results were presented at the American College of Rheumatology Congress in November.
Celltrion expects that the SC formulation will provide patients with a more convenient and personalized treatment option. The product can be injected by patients themselves, thus allowing for the potential to reduce hospital visits and save time for I.V. treatment administration. The company has applied for patent protection in around 100 countries throughout the U.S., Europe and Asia until 2038.
“We plan to take a market that is worth ₩10 trillion [US$8.5 billion] in the global tumor necrosis factor-alpha inhibitor market, which is now mainly led by first-line agents – Remicade [infliximab] by Janssen Biotech Inc., Humira [adalimumab] by Abbvie Inc. and Enbrel [etanercept] by Amgen Inc.,” a spokesman of Celltrion told BioWorld. “For marketing Remsima SC in Europe, we consider [using a] ‘prime similar’ strategy that can sell the product more expensively than the existing first-line agents.”
Remsima SC's price will likely fall between the first-line agents and second-line agents.
“About 25 percent of the patients using the first-line agents have low response rates to the treatments due to tolerance,” he said. “These patients need to use the second-line agents like Orencia [abatacept] by Bristol-Myers Squibb Co., Actemra [tocilizumab] by Roche Holding AG and Entyvio [vedolizumab] by Millennium Pharmaceuticals Inc., paying almost $20,000 a year.” The patients targeted by Celltrion’s SC version are those “who haven’t had much effect from the first agents and haven’t started using the second agents yet,” the spokesman added. “We will promote that Remsima SC is effective, economical and convenient to the patients.”
The company has submitted a variation to the marketing approval of Remsima SC to extend its indication to inflammatory bowel disease (IBD). That approval decision is expected to come out in mid-2020, and Celltrion plans to further accelerate the product marketing in the second half of next year.
Celltrion expects to launch Remsima SC in Europe in the first quarter of 2020. It plans to first launch in Germany in February, then in the U.K. and the Netherlands in March. By the end of 2020, the company aims to take 90% of the European TNF-alpha inhibitor market, which is estimated to be worth ₩9.2 trillion.
The biopharmaceutical giant will directly sell the product through its 14 branches, 300 sales employees and marketing network in Europe. Also, it is preparing for a nurse consultancy program, monitoring kits that can be used at patients’ home, and a mobile application intended to assist communications between patients and doctors as additional services.
In the U.S., the product is planned to enter the market in 2022.
“There are no competitor products in most European tender markets, which makes Remsima SC’s entry to the market easy and fast,” Seogwon Choi, analyst at Ebest Securities in Korea, told BioWorld.
“Also, the product launch in the U.S. market in 2022 may facilitate the positioning of a Humira biosimilar in the U.S., which is expected to be in 2023,” Choi added.
The global TNF-alpha inhibitors market is expected to touch $54.2 billion by 2025. According to a Research and Markets report, the global TNF-alpha inhibitors market will grow at a compound annual growth rate (CAGR) of 3.6% during the forecast period 2019-2025. The analysis said, in 2018, the adalimumab segment accounted for the largest share and is expected to grow at a mid-single-digit CAGR during the forecast period. Increased clinical efficacy and preference by physicians for the treatment of severe rheumatic diseases made the segment the largest market share in 2018.
North America accounted for the largest share of the global TNF-alpha inhibitors market in 2018 and will hold a high position during the forecast period. Europe followed North America, with a market share of more than 20% in 2018.