Celltrion Completes Resubmission to FDA for Proposed Trastuzumab Biosimilar
Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab).
Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last year, respectively. However, it received CRLs (complete response letters) from the FDA related to the warning letter issued by the FDA in January 2018, related to the manufacturing facility in Incheon, South Korea.
Celltrion had completed the resubmission for the approval of CT-P10, a proposed biosimilar to Rituxan® (rituximab) last month. 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 calendar year.
FDA has 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 the aBLAs.
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 is responsible for completing all clinical developments and regulatory activities.
The reference product for CT-P6 is Herceptin® (trastuzumab)1. Herceptin® is used to treat cancer patients whose tumors have either HER2 overexpression or HER2 gene amplification. Similarity of CT-P6 to the reference product, Herceptin®, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials. CT-P6 is currently pending FDA review and approval. The final U.S. prescribing information for CT-P6 will include the specific uses for which the product is indicated in the U.S. CT-P6 was approved by the European Commission (EC) in early 2018 and launched in certain parts of Europe.
CT-P10 was the world’s first monoclonal antibody (mAb) biosimilar approved by the European Commission (EC) for the treatment of oncology and launched in Europe in 2017. The reference product for CT-P10 is Rituxan® (rituximab)2. 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). CT-P10 is currently pending FDA review and approval. The final U.S. prescribing information for CT-P10 will include the specific uses for which the product is indicated in the U.S. 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.
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 Herceptin® is a registered trademark of Genentech, Inc
2 Rituxan® is a registered trademark of Biogen and Genentech USA, Inc
About Business Wire
(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
Study Investigates the Ability of Continuous Noninvasive Hemoglobin Monitoring with Masimo SpHb® to Reflect Acute Hemodilution During Incremental Fluid Administration22.7.2019 06:00:00 CEST | Press release
Masimo (NASDAQ: MASI) announced today that in a study recently published in Anesthesia & Analgesia, researchers evaluated the ability of noninvasive and continuous hemoglobin monitoring with Masimo SpHb® to detect the development of acute hemodilution after graded fluid administration, by comparing it to invasively measured laboratory hemoglobin (BHb), on patients undergoing major surgery.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190721005044/en/ Masimo Root® with SpHb® and PVi® (Photo: Business Wire) In the study, Dr. Şerban Bubenek-Turconi and colleagues at the Carol Davila University of Medicine and Pharmacy and the Prof. C.C. Iliescu Institute for Cardiovascular Diseases in Bucharest, Romania, and Sheba Medical Center in Tel Aviv, Israel, examined the effects of incremental fluid loading (as part of perioperative goal-directed therapy (GDT)) on oxygen delivery and whether noninvasive SpHb monitoring could reliably
Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn's Disease22.7.2019 05:00:00 CEST | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced top-line results from the VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab as maintenance therapy in adult patients with moderately to severely active Crohn's disease (CD) who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) therapy at weeks 0 and 2.1 In evaluating the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission** at week 52 compared to placebo. Patients received vedolizumab SC beginning at week 6 and every 2 weeks up to week 50.1 Adverse events were consistent with the known safety profile of vedolizumab IV, and no new signals were identified. “Meeting the primary endpoint of the VISIBLE 2 study marks a crucial step in our efforts to help patients with Crohn
FDA Approves OTEZLA® (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease19.7.2019 17:59:00 CEST | Press release
Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. OTEZLA, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only approved treatment option for oral ulcers associated with Behçet’s Disease, a rare, chronic, multisystem inflammatory disease that is difficult to treat. “Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s Disease, and have an important negative impact on the quality of life for these patients,” said Yusuf Yazici, M.D., Clinical Associate Professor, Department of Medicine, New York University Langone Health. “In the clinical trial, OTEZLA demonstrated improvements in measures of oral ulcers at week 12. OTEZLA has the potential to be a needed treatment option for U.S. patients and their physicians, who
Abiraterone Acetate Included in World Health Organisation’s Essential Medicines List for the Treatment of Metastatic Castration-Resistant Prostate Cancer19.7.2019 13:05:00 CEST | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson is delighted with the recent announcement from the World Health Organisation (WHO) to include abiraterone acetate (ZYTIGA ® ) for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in the updated Essential Medicines List, published on 9th July 2019.1,2 The WHO’s Essential Medicines List is a core guidance document that helps countries prioritise critical health products that are recommended to be widely available and affordable throughout health systems.1 “The inclusion of abiraterone acetate in the WHO Essential Medicines List highlights the critical role that this treatment can play in improving the lives of patients living with mCRPC and their families,” said Dr. Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. “I am proud that we are working hard to impact survival and quality of life by developing and providing innovative medicines which ar
Gilead Sciences Licenses Respiratory and Herpes Antiviral Research Programs From Novartis19.7.2019 12:30:00 CEST | Press release
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has licensed three preclinical antiviral programs from Novartis, including investigational agents with the potential to treat human rhinovirus, influenza and herpes viruses. Under the agreement, Gilead will acquire exclusive global rights to develop and commercialize novel small molecules against three undisclosed targets. Novartis will receive an upfront payment and is eligible to receive up to an additional $291 million in potential milestone payments upon achievement of certain development and commercial milestones, as well as royalties on annual net sales. “Today’s announcement builds on Gilead’s heritage in antiviral research and development. We look forward to applying this expertise to advance the development of potential new treatments for viruses with limited therapeutic options,” said John McHutchison AO, MD, Gilead’s Chief Scientific Officer and Head of Research and Development. Gilead’s antiviral portfolio include
Schlumberger Announces Second-Quarter 2019 Results19.7.2019 11:00:00 CEST | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2019. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2019 Mar. 31, 2019 Jun. 30, 2018 Sequential Year-on-year Revenue $8,269 $7,879 $8,303 5% 0% Pretax segment operating income $968 $908 $1,094 7% -12% Pretax segment operating margin 11.7% 11.5% 13.2% 17 bps -148 bps Net income - GAAP basis $492 $421 $430 17% 14% Net income, excluding charges & credits* $492 $421 $594 17% -17% Diluted EPS - GAAP basis $0.35 $0.30 $0.31 17% 13% Diluted EPS, excluding charges & credits* $0.35 $0.30 $0.43 17% -19% North America revenue $2,801 $2,738 $3,139 2% -11% International revenue $5,463 $5,037 $5,065 8% 8% North America revenue, excluding Cameron $2,243 $2,178 $2,546 3% -12% International revenue, excluding Cameron $4,761 $4,469 $4,387 7% 9% *These are non-GAAP financial measures. See section titled "Charges & Credits" for details. Schlumberger Chairman and CEO Paal Kibsgaard commente