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Celltrion Inc. Company Profile

03:47 EDT 23rd October 2018 | BioPortfolio

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 EMA 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. Celltrion also received EMA approval for Truxima® (CT-P10, a mAb biosimilar to MabThera®iv (rituximab)) in February 2017. For more information, visit www.celltrion.com.


News Articles [106 Associated News Articles listed on BioPortfolio]

Federal judge: Celltrion's Inflectra does not infringe on Remicade patent

Celltrion won against Johnson & Johnson unit Janssen Biotech's patent-infringement lawsuit regarding Celltrion's biosimilar I -More- 

Rejection: FDA Issues CLRs for Two Celltrion and Teva Biosimilars

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.

FDA declines proposed Rituxan, Herceptin biosimilars from Celltrion

The FDA has rejected approval of Celltrion’s biologics license applications for Truxima, a proposed rituximab biosimilar, and Herzuma, a proposed trastuzumab biosimilar, issuing Complete Response Le...

Celltrion Completes Resubmission to FDA for CT-P6, a Proposed Trastuzumab Biosimilar

INCHEON, South Korea–(BUSINESS WIRE)–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 m...

FDA panel endorses Celltrion’s biosimilar to Rituxan

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has recommended approval of Celltrion’s Rituxan biosimilar CT-P10. CT-P10...Read More... The post FDA panel endor...

US FDA rejects Teva biosimilars made at troubled Celltrion plant

The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrionâs facility received a warning in Janaury.

Celltrion Completes Resubmission for Biosimilar Candidate CT-P10 to FDA for Review

INCHEON, South Korea–(BUSINESS WIRE)–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),...

Celltrion hit with Form 483 over troublesome Incheon plant

Celltrion has told shareholders its manufacturing site received a Form 483 from the US FDA.

Drugs and Medications [0 Results]

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PubMed Articles [0 Results]

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Clinical Trials [1 Associated Clinical Trials listed on BioPortfolio]

A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis

A new subcutaneous infliximab formulation is being developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less th...

Companies [5 Associated Companies listed on BioPortfolio]

Celltrion Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltr...

Celltrion, Inc.

Based in Incheon, Republic of Korea, Celltrion, Inc. is a global biopharmaceutical leader with strong research and development capabilities in biosimilar monoclonal antibodies (mA...

Celltrion

Celltrion is a biopharmaceutical manufacturing company dedicated to supplying the next generation of biopharmaceutical products to the global community. Our seasoned management team, favorable cost ...

Teva Pharmaceutical Industries Ltd. and Celltrion, Inc.

Celltrion Healthcare

Satellite symposium 3a: Remsima™, the 1st biosimilar monoclonal antibody, Friday 20 February 07:15-08:15

More Information about "Celltrion Inc." on BioPortfolio

We have published hundreds of Celltrion Inc. news stories on BioPortfolio along with dozens of Celltrion Inc. Clinical Trials and PubMed Articles about Celltrion Inc. for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Celltrion Inc. Companies in our database. You can also find out about relevant Celltrion Inc. Drugs and Medications on this site too.

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