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Samsung Bioepis's Beval sing-it-againbiolya AYBINTIO is positively rated by CHMP

 Last Update: 2020-07-13
 Source: Internet
 Author: User

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South Korea's Samsung Bioepis recently announced that the European DrugAdministrationBureau (EMA) of the Human Drug Commission (CHMP) is positive about AYBINTIO, the drug is a biosimilar of beflopaCHMP recommends the use of AYBINTIO for beta-suprothem-based indications, including metastaticcolorectal cancer(mCRC), metastaticbreast cancer(mBC), non-small cell lung cancer (
NSCLC), metastatic renal cell cancer (mRCC), epithelialovarian cancer, primary peritonic cancer and cervical cancerThe European Commission (EC) will review CHMP's positive comments to decide whether to grant AYBINTIO marketing licences"High-quality biosimilars are an important means of reducing the financial burden on patients," said Hee Kyung Kim, senior vice president of clinical science at Samsung BioepisOnce approved, AYBINTIO will be an effective treatment option for different types of cancer and may help many patients in Europe."AYBINTIO's Market Authorization Application (MAA) is supported by pharmacokinetics (PK) and clinical data, as well as pharmacological and toxicological data, which show that AYBINTIO is highly similar to BevalsingIn addition, the company filed a biologics licensing application (BLA) for AYBINTIO in September 2019 and is currently under review by the U.S FDA

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