Celltrion USA’s commitment to meeting patient demand for affordable and effective biologics

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It has been seven years since the US Food and Drug Administration approved Celltrion’s Remsima^® [marketed as Inflectra^® (infliximab-dyyb) in the US through a commercial agreement with Pfizer]. ^1,2 The US biologics market is continuing to grow and now comprises almost half (46%) of spending.³ Since the first biosimilar launch in 2015, biosimilars enabled savings totaling $24 billion, with infliximab biosimilar savings accounting for $3.3 billion of this amount.⁴

With the introduction of our infliximab biosimilar, Celltrion made a commitment to patients to provide affordable and effective biologics and innovative therapies. Fast forward to 2023, Celltrion is now established in the USA fully extending this commitment to US patients. To better serve our US customers, Celltrion is also expanding US operations to include research and commercial functions.

A landmark event in establishing Celltrion’s US commercial presence was the launch of Vegzelma^® (bevacizumab-adcd), a biosimilar to Avastin^® (bevacizumab).⁵ For more information about Vegzelma, see full Prescribing information, including Boxed Warning at www.vegzelma.com.

Following on from Vegzelma, Celltrion recently launched Yuflyma^® (adalimumab-aaty), which was approved by the FDA in May 2023. Yuflyma is a citrate-free, high concentration biosimilar to Humira^® (adalimumab).⁶ Yuflyma is currently approved for eight conditions.⁷ For more information about Yuflyma, see full Prescribing information, including Boxed Warning at www.yuflyma.com.

In addition to our approved biosimilar products, Celltrion has a robust and continuously expanding pipeline of products designed to provide effective and affordable treatments to patients across a wide range of health conditions.

In June 2023, Celltrion filed for FDA approval of CT-P42, an investigational biosimilar to Eylea^® (aflibercept), based on positive phase 3 clinical trial results that were recently presented in 2023.^8,9 Celltrion also filed application for CT-P43, proposed Stelara^® (ustekinumab) biosimilar to the US FDA in June 2023 and reached a settlement and license agreement with Johnson & Johnson (J&J).¹⁰ In addition, the FDA accepted the company’s investigational new drug (IND) application to conduct a phase 3 study evaluating CT-P53, a biosimilar referencing Ocrevus^® (ocrelizumab).¹¹

Beyond our portfolio of biosimilars, Celltrion is also developing novel biologics that are intended to provide additional options for physicians and patients. This includes CT-P13 SC, an investigational, subcutaneous (SC) version of infliximab that is currently under FDA review as a novel biologic via the 351(a) biologics license application (BLA) pathway.

To further strengthen our research and development capabilities, Celltrion has built a new Global Research and Development (R&D) Center at the site of our research institute in Songdo International City, Incheon, Korea. With its state-of-the-art research facilities, the facility will serve as the hub for developing next-generation biopharmaceuticals and small-molecule drugs. Here we will develop innovations across many areas, including antibody-drug conjugates (ADCs), bispecific antibodies and new drug platforms.

To meet the growing global demand for biologics, we are also expanding our manufacturing capacity. This year, Celltrion expects to complete a third plant, which will feature a multi-variety production and supply system with a capacity of 60,000 liters per year. The first two plants have a production capacity of 102,000 liters and 90,000 liters, respectively. Therefore, once the new plant is completed, Celltrion will have the capacity to produce a total of 252,000 liters of biopharmaceuticals per year, ensuring a stable supply.

With this expansion of our core infrastructure, Celltrion is enhancing its ability to respond proactively to the rapidly growing global demand for biologics, while further strengthening our R&D. As we look forward to the next decade and beyond, we will continue to enhance our capabilities to expand patient access to even more biologic therapies.

1. Remsima^® is a registered trademark of Celltrion, Inc. used under license.
2. Inflectra^® is a registered trademark of Pfizer, Inc.
3. Biosimilars in the United States 2023-2027. IQVIA. iqvia-institute-biosimilars-in-the-united-states-2023-usl-orb3393.pdf. Accessed August 30, 2023.
4. The U.S. Generic & Biosimilar Medicines Savings Report. September 2023. Association for Accessible Medicines. https://accessiblemeds.org/sites/default/files/2023-09/AAM-2023-Generic-Biosimilar-Medicines-Savings-Report-web.pdf. Accessed August 30, 2023.
5. Avastin^® is a registered trademark of Genentech, Inc.
6. Humira^® is a registered trademark of Abbvie, Inc.
7. Yuflyma^® prescribing information. https://www.celltrionusa.com/data/file/product/Yuflyma%20USPI.pdf. Celltrion, Inc. Accessed August 30, 2023.
8. Eylea^® is a registered trademark of Regeneron Pharmaceuticals, Inc.
9. Brown DM et al. Efficacy and safety of CT-P42 compared to reference aflibercept (AFL) in diabetic Macular edema (DME): 24-week results from the phase 3 CT-P42 3.1 study. Late-breaking abstract, presented at 40th Annual ASRS Meeting, July 28-August 1, 2023, Seattle, WA
10. Stelara^® is a registered trademark of Johnson & Johnson Services, Inc.
11. Ocrevus^® is a registered trademark of Genentech, Inc.