Celltrion Completes Resubmission for Biosimilar Candidate to FDA for Review
Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P10 (rituximab), a proposed mAb biosimilar to Rituxan®.
Additionally, Celltrion plans on making a resubmission for the approval of CT-P6, a proposed biosimilar to Herceptin® in June. In accordance with FDA regulations, the approval procedure will be usually finalized within six months from the resubmission, so Celltrion expects the approval for the U.S. market of the two proposed biosimilars within this year.
Celltrion submitted Biologics License Applications (BLAs) for CT-P10 and CT-P6 to the U.S. FDA in April and May of last year, respectively. However, it received CRLs (complete response letter) from the FDA related to the Warning Letter issued by the FDA in January 2018, regarding the manufacturing facility in Incheon, South Korea.
Celltrion has made progress addressing the concerns raised by the FDA in the Warning Letter and is committed to working with the Agency to fully resolve all outstanding issues with the highest priority and urgency.
FDA has recently notified Celltrion of its re-inspection schedule regarding regular audit results, and separately from this procedure, it has confirmed the resumption of the review procedure for the two proposed biosimilars upon the resubmission of BLAs.
Celltrion official said: “Celltrion is confident that CT-P10 and CT-P6, following the success of REMSIMA® (INFLECTRA®) around the globe, will be the alternative oncology treatment options for the patients in the U.S. with proven record of quality, efficacy and safety to the reference product at an affordable price.”
Celltrion and Teva Pharmaceutical Industries, Ltd. entered into an exclusive partnership to commercialize CT-P10 and CT-P6 in the U.S. and Canada in October 2016. As part of the agreement, Teva is responsible for all commercial activities in the U.S. and Canada, pending regulatory approvals for both products. Celltrion has responsibility for completing all clinical development and regulatory activities.
About CT-P10
CT-P10 was the world’s first monoclonal antibody (mAb) biosimilar approved by the European Commission (EC) for the treatment of oncology. The EC approved CT-P10 for the same indications as the reference product, based on data demonstrating comparability in terms of quality, efficacy and safety. The reference product for CT-P10 is Rituxan®1. Rituxan is used to treat patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Rituximab, the active substance in CT-P10, has been designed to bind specifically to the transmembrane protein CD20 found on both malignant and normal B cells. In 2017, CT-P10 was launched in Europe.
About CT-P6
CT-P6 is an anticancer monoclonal antibody (mAb) biosimilar drug used to treat early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. Similarity of CT-P6 to the reference product, Herceptin®2, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials. In 2018, CT-P6 was approved by EC and launched in Europe.
About Celltrion, Inc.
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for INFLECTRA® and Remsima®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com.
1 Rituxan® is a registered trademark of Biogen and Genentech USA, Inc
2 Herceptin® is a registered trademark of Genentech, Inc
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180529006382/en/
Contact information
Celltrion, Inc.
Gunn Lee, +82 32 850 5168
Gunhyuk.lee@celltrion.com
or
Heewon
Park, +82 32 850 5356
Heewon.park@celltrion.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
VeriSilicon Launches the Industry-Leading Automotive-Grade Intelligent Driving SoC Design Platform29.4.2025 03:00:00 EEST | Press release
VeriSilicon (688521.SH) recently announced that its automotive-grade high-performance intelligent driving system-on-chip (SoC) design platform has been verified and successfully implemented in customer projects. Leveraging VeriSilicon’s Silicon Platform as a Service (SiPaaS) business model, this platform provides robust technical support for high-performance computing applications such as autonomous driving and advanced driver assistance systems (ADAS). VeriSilicon’s chip design process has obtained ISO 26262 automotive functional safety management system certification, enabling the company to provide global customers with one-stop custom service for their automotive chips that meet functional safety requirements. Combined with its extensive portfolio of automotive-grade IPs and complete intelligent driving software platform, VeriSilicon offers end-to-end support from chip design and verification to automotive certification, including safety requirement analysis, architecture design, a
EU Authorisation Allows for Fermented Rapeseed Cake to Be Applied in Food29.4.2025 00:59:00 EEST | Press release
Most people recognise the yellow, fragrant rapeseed fields that adorn the landscape in spring. But few know that rapeseed cake was banned as food grade until today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250428371892/en/ Today is a special day for Danish FERM FOOD ApS, which has received the EU Commission's authorisation to use fermented rapeseed cake as a food ingredient (Left: Founder and CEO Jens Legarth, right: Head of Development Søren Lange). Rapeseed was banned – until today Rapeseed, also known as Canola, is primarily grown for its oil-rich seeds, which are pressed into cooking oil. While you can fill the pan with rapeseed oil, the remaining protein-rich press cake is strictly forbidden for human consumption in the EU until today. Therefore, rapeseed cake is primarily used for feed and biogas. The EU rule that prohibits rapeseed for consumption is called Novel Food and means that only foods that have been con
IFF Pharma Solutions to Showcase Portfolio at Excipient World 202529.4.2025 00:00:00 EEST | Press release
IFF (NYSE: IFF) Pharma Solutions, a global leader in polymer innovations, will showcase its sustainable solutions at Excipient World 2025. The team will feature sustainable innovations, controlled-release formulations, and nitrosamine risk mitigation solutions at booth 205 from May 13-14, Gaylord National Resort and Convention Center, National Harbor, Maryland, USA. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250428283122/en/ “At IFF Pharma Solutions, we believe sustainability is not just a responsibility but an opportunity to innovate and inspire,” said Dr. Anne Adden, global strategic marketing director for sustainability and dietary supplements. “We are committed to creating solutions that not only meet the needs of today but also pave the way for a healthier, more sustainable future. Our team of problem-solvers and experts is redefining what it means to lead in sustainable healthcare.” Building on over 75 years of ind
KILL Svante and Mercer International Advance Carbon Capture Project at Alberta Pulp Mill28.4.2025 23:34:00 EEST | Press release
Svante requests that their press release NewsItemId: 20250428544430 “Svante and Mercer International Advance Carbon Capture Project at Alberta Pulp Mill” be killed. The release was issued prematurely by Svante. A replacement release will be issued within the next 48 hours.
Winka Dubbeldam Appointed Director and CEO of SCI-Arc28.4.2025 21:50:00 EEST | Press release
The Southern California Institute of Architecture (SCI-Arc) is thrilled to share that Prof. Winka Dubbeldam has been appointed as the next Director and Chief Executive Officer of SCI-Arc. A globally recognized Dutch architect, educator, and leader in design innovation, Winka will officially assume the role on September 1, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250428994100/en/ Winka Dubbeldam Winka brings more than three decades of experience to the forefront of architectural practice and education. She is a full Professor of Architecture and served as Chair at the University of Pennsylvania Stuart Weitzman School of Design for ten years (2013–2023). Previously she initiated and directed the Post-Professional Architecture program for ten years (2003–2013), providing international students with innovative design skills, cutting-edge theoretical and technological knowledge necessary for a productive and innovativ
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom