Celltrion Healthcare (Formerly Known As Celltrion)
1000 Marina Boulevard
About Celltrion Healthcare (Formerly Known As Celltrion)Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines.
CEO: Jung Jini
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78 articles with Celltrion Healthcare (Formerly Known As Celltrion)
Celltrion Partners with the Canadian Biotech Company, iProgen Biotech to Develop a Series of Novel ADCs
The deal aims to co-develop up to 4 ADCs including a novel ADC (Antibody-drug conjugate) that targets breast cancers expressing low levels of HER2 using iProgen’s proprietary antibody drug delivery technology.
The U.S. Food and Drug Administration approved another biosimilar. On Friday, the regulatory agency approved Herzuma, a biosimilar to Genentech’s Herceptin developed by South Korea-based Celltrion, Inc. and Israel-based Teva Pharmaceuticals.
Celltrion Healthcare: Biosimilars Have the Potential to Deliver Dramatic Cost Savings for US and European Healthcare Systems
As the global leader in biosimilars, Celltrion Healthcare aims to positively shape future healthcare by improving patient access to biosimilars
In August, Pfizer filed with the U.S. Food and Drug Administration (FDA) accusing Amgen and Roche of using social media to mislead doctors and patients about biosimilars and their effectiveness.
Celltrion and Teva Announce FDA Oncologic Drugs Advisory Committee Recommends Approval of Celltrion BLA for CT-P10, a Proposed Rituximab Biosimilar
If approved, CT-P10, a proposed biosimilar to Rituxan® (rituximab), will be the first rituximab biosimilar to be approved in the United States.
Celltrion Finalizes Clinical Trials for Remsima SC, Planning to File a Marketing Authorization Application to the EMA in H2
Completing clinical trials for the patient convenience-enhanced ‘Remsima SC’, the subcutaneous version of Remsima®, to file a Marketing Authorization Application to the European Medicines Agency
Last week, Teva Pharmaceutical released what tried to be an optimistic second-quarter financial report, despite revenues that had decreased by 18 percent and softening sales of its biggest product, Copaxone.
Celltrion is set to develop CT-P17 as a high-concentration formulation, differentiating it from competitive biosimilars
Celltrion 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).
New subcutaneous formulation of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) shows positive results for the treatment of active Crohn’s disease in data presented at Digestive Disease Week® 2018
Celltrion Healthcare presented new research at Digestive Disease Week® (DDW) 2018, that shows the efficacy and safety of the CT-P13 subcutaneous (SC) formulation is comparable to the CT-P13 intravenous (IV) formulation up to week 30 in patients with active Crohn’s disease (CD).
Celltrion made an announcement that it will launch Bio CDMO (Contract Development and Manufacturing) business
Celltrion and Yonsei University Health System Team up to Develop New Drugs for Cerebrovascular Diseases
Reinforcing the new biopharmaceutical pipeline: Joint development and license-in agreement with Yonsei University Health System
Celltrion 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®.
On May 19 every year the people who are afflicted with IBD disorders unite across the globe to raise awareness of the disease and urge governments and healthcare systems to continue to focus on the development of necessary treatments.
According to Biosimilarpipeline, more than 660 companies worldwide have about 700 biosimilars in development.
The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to Sandoz, a division of Novartis, for its Biologics Licensing Application (BLA) for its biosimilar to Roche/Genentech’s Rituxan.
The FDA Giveth and Taketh Away: Grants Pfizer's MenB Breakthrough Therapy Designation and Turns D...
4/23/2018The FDA granted Pfizer’s Trumenba, a vaccine for meningococcal B disease in children ages one to nine years, Breakthrough Therapy Designation and declined to approve its biosimilar of Roche's Herceptin for breast cancer.
The FDA issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. Teva Pharmaceutical Industries signed a deal in 2016 with Celltrion to commercialize the two biosimilars.
Celltrion are down more than 5 percent after the company announced it received a warning letter from the FDA after the regulatory agency inspected a company drug manufacturing facility.
Celltrion, the little-known South Korean biotech company that surged into the ranks of the world's most-traded stocks at the start of 2018, may finally be coming down to Earth.