Business Wire

Celltrion Completes Resubmission for Biosimilar Candidate to FDA for Review

Share

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

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Gilead Sciences to Release Second Quarter 2019 Financial Results on Tuesday, July 30, 201916.7.2019 20:05:00 CESTPress release

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its second quarter 2019 financial results will be released on Tuesday, July 30, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the second quarter 2019 and provide a business update. The live webcast of the call can be accessed at the company’s Investors page at http://investors.gilead.com/. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 8696029 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, August 1, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the confere

MSCI Schedules Investor Conference Call to Review Second Quarter 2019 Results16.7.2019 14:49:00 CESTPress release

MSCI Inc. (NYSE: MSCI), a leading provider of critical decision support tools and services for the global investment community, announced today it will release its results for second quarter 2019 on Thursday, August 1, 2019. MSCI's senior management will review the second quarter 2019 results on Thursday, August 1, 2019 at 11:00 AM Eastern Time. To listen to the live event, visit the events and presentations section of MSCI's Investor Relations homepage, http://ir.msci.com/events.cfm, or dial 1-877-376-9931 conference ID: 7743929 within the United States. International callers dial 1-720-405-2251 conference ID: 7743929. The earnings release and related investor presentation used during the conference call will be made available on MSCI's Investor Relations homepage. An audio recording of the conference call will be available on our Investor Relations website, http://ir.msci.com/events.cfm, beginning approximately two hours after the conclusion of the live event. Through August 4, 2019,

Keio Plaza Hotel Tokyo Offers “Tea Ceremony Experience and Luxurious Accommodations for Families” Package16.7.2019 14:05:00 CESTPress release

Keio Plaza Hotel Tokyo (KPH), one of Japan’s most prestigious international hotels located in Shinjuku, Tokyo, will begin offering a special summer accommodation package entitled “Tea Ceremony Experience and Luxurious Accommodations for Families” from July 20 to September 1, 2019. This accommodation package has been specially designed to keep families with children entertained by providing the unique cultural experience of a Japanese tea ceremony as fond memories of their summer vacation at our Hotel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190716005325/en/ With the accommodation package, guests with children could experience unique cultural Japanese tea ceremony to learn how to make a green tea and its history. (Photo: Business Wire) The rooms offered in this accommodation package are the very popular “Two Queen Beds Rooms” located on the “Premier Grand” club floors with use of the Club Lounge included. The rooms are

Andersen Global Enters Senegal, Expands Presence in Africa16.7.2019 13:30:00 CESTPress release

Andersen Global is proud to announce a collaboration agreement with Cabex, one of the oldest legal and tax consulting firms in Senegal. Senegal thus becomes the thirteenth African country where Andersen Global has a member or collaborating firm offering legal services. Located in Dakar, Cabex has been offering services to local and foreign clients from the public and para-public sectors on matters relating to national and international issues for nearly thirty years. “Collaborating with Andersen Global shall expand our international scope and our transborder capabilities while giving us additional opportunities to expand into new markets,” Papa Alassane Ndir, Partner & General Manager at Cabex, said. “Henceforth, we are going to collaborate with many colleagues and experts from around the world and will be in a position to provide our clients more in-depth expertise.” Cherif Diaite, Partner & Technical Manager at Cabex, indicated that, “Owing to the challenge at an international level,

Mercatus Opens UK Office; Hires Chris Webb to Lead European Operations16.7.2019 13:00:00 CESTPress release

Mercatus, a leading asset and investment management platform for alternative investors and asset managers, today announced the opening of its European Headquarters in London, UK and the addition of Chris Webb as Senior Director leading the office in London. Chris was formerly a Global Director of Strategic Business Growth at FIS, with a deep focus on, and expertise in, alternative investments. “As Alternative fund managers and investors across Europe continue to embrace technology – and data – as a competitive weapon to drive future accelerated growth, we’re putting our resources in some of the largest markets. Our London office will be a critical hub for our workings in the UK, expanding upon our other offices in Silicon Valley, New York, Austin, Rome and Pune, India,” said Haresh Patel CEO of Mercatus. “We will continue to expand our local presence across Europe and Asia as our customers have deal and asset management teams in 118 countries with $540B AUM operating within the Mercatu

LivaNova Combats Leg Ischemia with Breakthrough Bidirectional Cannula16.7.2019 13:00:00 CESTPress release

LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today launched its innovative arterial femoral cannula, Bi-Flow, designed to prevent limb ischemia during cardiac surgery. LivaNova Bi-Flow received CE Mark earlier this year and is the only bidirectional arterial cannula designed to prevent leg ischemia during cardiac surgery procedures requiring femoral artery cannulation. In a clinical study, Bi-Flow was easily inserted and removed without complications and was proven to provide simultaneous systemic and distal perfusion of the limb in a safe and reproducible way.1 Leg ischemia is caused by compromised blood flow to a lower limb and can affect up to 11% of patients undergoing complex cardiac surgery procedures.2 Consequences can include higher mortality, higher morbidity and longer hospital stays.3 The first procedure in Europe using a Bi-Flow cannula was performed by Patrick Perier M.D., FACS, at the Cardiovascular Center of Bad Neustadt, Germany. “I truly bel