Business Wire

Celltrion Completes Resubmission for Biosimilar Candidate to FDA for Review

Jaa

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

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

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Knopp Biosciences Presents Positive Preclinical Data for Lead Neonatal Epilepsy Drug Candidate at 2019 Antiepileptic Drug and Device Trials XV Conference24.5.2019 17:00:00 EESTTiedote

Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases of high unmet need, today presented in vitro and in vivo data for the company’s lead molecule for the targeted treatment of KCNQ2-neonatal epileptic encephalopathy (KCNQ2-NEE) at the Antiepileptic Drug and Device Trials XV Conference in Miami, Florida. KCNQ2-NEE, a rare infant genetic epilepsy, results from mutations in genes encoding the Kv7.2/Kv7.3 ion channel, leading to frequent seizures and profound developmental delay. The preclinical data were presented by Steven Dworetzky, Ph.D., Knopp’s Chief Scientific Officer, a longtime Kv7 researcher who led the group that first cloned the Kv7.2 and Kv7.3 genes during his former tenure with the Bristol-Myers Squibb Co. Dr. Dworetzky presented results demonstrating the in vitro nanomolar activity of KB-3061 and its significant seizure protection in the maximal electroshock mo

Accelerate Your Business in South Korea Through 2019 K-Startup Grand Challenge24.5.2019 13:20:00 EESTTiedote

Entrepreneurs from across the globe should set their sights on participating in the 2019 K-Startup Grand Challenge. Supported by the Ministry of SMEs and Startups and National IT Industry Promotion Agency (NIPA) of South Korea, the initiative provides invaluable support and comprehensive resources to early age startups. Applications for the K-Startup Grand Challenge are currently being accepted through June 14, 2019. In order to advance in the program, teams must pass a regional audition. A judging panel of startup ecosystem experts and Korean accelerators will select 40 teams to participate in an enriching 3.5 month-long acceleration program in Korea. The selected teams will have exclusive access to free office space at the Startup Campus in Pangyo Techno Valley, one-on-one mentoring, information sessions, coaching on Korean and Asian business culture and the chance to attend insightful seminars on accounting regulations to tax laws, patents and more. Opportunities for networking with

New Investigational Clinical Data for Ipsen’s Oncology Products in 11 Solid Tumor Types to Be Presented at 2019 ASCO Annual Meeting24.5.2019 08:00:00 EESTTiedote

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that new data from clinical studies on investigational uses of cancer medicines cabozantinib (Cabometyx®), liposomal irinotecan (Onivyde®), and lanreotide autogel (Somatuline®, marketed as Somatuline Depot® in the United States) will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting takes place in Chicago, Illinois, U.S., 31 May–4 June 2019; data featuring Ipsen medicines includes: New data from the Phase 3 CELESTIAL trial on the association of adverse events with efficacy outcomes for cabozantinib in patients with advanced hepatocellular carcinoma Overview of the Phase 3 COSMIC-312 trial of cabozantinib in combination with atezolizumab vs sorafenib in patients with advanced hepatocellular carcinoma who have not received previous systemic anticancer therapy First Phase 2 data from the CaboGIST study (trial 1317) from the European Organization for Research and Treatment of

The Posiflex Group Showcases an Ecosystem of Connected Solution Endpoints with IoT Remote Monitoring at Computex 201924.5.2019 04:00:00 EESTTiedote

For the Computex 2019 show, The Posiflex Group is featuring leading solution technology from the family of brands as a fully Serviced IoT Ecosystem. Solution end points include: Connected Modular Kiosks, POS Terminals, and Digital Signage solutions from Posiflex and KIOSK Information Systems Smart Medical Displays with gesture controls from Portwell Connected Gaming Solutions with Player Tracking Technology from Portwell subsidiary, Ganlot The booth display is based on common field service endpoints represented in a European Manor Destination Resort setting. Field solutions for an array of vertical market applications include QSR ordering, cinema ticketing, fashion retail customer loyalty, interactive signage, hotel / medical center check-in and bill pay, as well as casino gaming technology. This year, in addition to their renowned POS product suite, Posiflex will be featuring newly introduced Modular Kiosk platforms (co-designed by KIOSK and Posiflex), which are configure-to-order sta

Audi China President Thomas Owsianski to Keynote at CES Asia 201923.5.2019 23:00:00 EESTTiedote

The Consumer Technology Association (CTA)TM today announced that Thomas Owsianski, president of Audi China, will deliver a keynote address at the upcoming CES Asia 2019. Now in its fifth year, CES Asia will run June 11-13, 2019 at the Shanghai New International Expo Centre (SNIEC) in Shanghai, China. Thomas Owsianski’s keynote is scheduled for 4 PM, Tuesday, June 11, where he will unveil Audi’s vision in transforming mobility from a driving experience to a digital adventure. Mr. Owsianski joined the top management team of Audi China in August 2018 and was named President in October 2018. “Audi has been at the forefront of driving global transformation in the automotive industry through their breakthrough advancements in technology,” said Karen Chupka, executive vice president, CES. “Innovation has revolutionized the transportation experience, and we welcome Mr. Owsianski to the CES Asia stage to share Audi’s vision for the future of global mobility.” Throughout Asia and beyond, technol

ITechLaw Publishes New Book and Opens Global Public Comment Period on Draft Principles for Responsible Artificial Intelligence23.5.2019 22:11:00 EESTTiedote

The International Technology Law Association (ITechLaw) has published Responsible AI: A Global Policy Framework, a new book that provides an in-depth review and eight discussion principles that address some of the hottest technology and moral issues of responsible development, deployment and use of artificial intelligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190523005752/en/ ITechLaw releases new book, Responsible AI: A Global Policy Framework, and opens public comment period. (Photo: Business Wire) Written by a multi-disciplinary group of 54 technology law experts, industry representatives and researchers from 16 countries, the book offers an actionable framework built on the following principles: Ethical Purpose and Societal Benefit, Accountability, Transparency and Explainability, Fairness and Non-discrimination, Safety and Reliability, Open Data and Fair Competition, Privacy, and AI and Intellectual Property.

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme