Celltrion Inc. Company Profile

23:18 EDT 19th April 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

News Articles [73 Associated News Articles listed on BioPortfolio]

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...

Why Booming Celltrion Started Crashing Last Week

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.

Hikma to sell Celltrion's Rituxan biosimilar in Africa, Middle East

The London-based generics company already markets in the MENA region two other copycat biologics developed by Celltrion.

Positive phase III switching results for Celltrion’s infliximab biosimilar

Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) infliximab biosimilar (CT-P13) is shown to be comparable in efficacy and safety to Johnson & Johnson/Mer...

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.

Safe to switch from Rituxan to our biosimilar in RA, says Celltrion

Korean drugmaker Celltrion Healthcare has presented data supporting switching to its biosimilar version…

Celltrion’s drive remains relentless despite being joined on ‘lonely path’ by host of biosimilar manufacturers

It was no fluke when Celltrion Healthcare became the first drug developer to win approval for a biosimilar…

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PubMed Articles [0 Results]


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 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

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Relevant Topics

Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Products that ar...

Monoclonal antibodies MAbs
Monoclonal antibodies recognise and attach to specific proteins produced by cells.  Types of monoclonal antibodies used to treat cancer cells: Block cell dividing dividing signals Transport cancer drugs or radiation to cancer cells Tr...

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