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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.
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...
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...
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.
The US FDA has issued complete response letters (CRL) for the Rituxan and Herceptin biosimilar candidates after Celltrionâs facility received a warning in Janaury.
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),...
It was no fluke when Celltrion Healthcare became the first drug developer to win approval for a biosimilar…
Rejection by the FDA of the two biosimilar candidates Celltrion develops with Teva could also prove a headache for the Israeli drugmaker's migraine treatment.
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...
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltr...
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 ...
Satellite symposium 3a: Remsimaâ¢, the 1st biosimilar monoclonal antibody, Friday 20 February 07:15-08:15
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.
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...