The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on Imraldi (adalimumab), an investigational biosimilar drug of Samsung Bioepis, the South Korean biopharmaceutical company announced last Saturday.

The CHMP recommendation will now be reviewed by the European Commission (EC), which holds the authority to approve medicines for the European Union (EU). The EC typically follows the CHMP recommendation and issues an approval decision within two to three months.

If approved, doctors would be given the discretion to select the therapy as an alternative to Humira, the patented reference drug for use to treat autoimmune diseases. Humira manufactured by U.S. pharmaceutical company AbbVie generated about 18 trillion won ($15.8 billion) in global sales last year. The world’s top-selling drug with multiple autoimmune indications including rheumatoid arthritis and ulcerative colitis represents more than 60 percent of AbbVie revenue.

“This positive CHMP opinion means that our research and development has been recognized by the European scientific community once again, and if approved we could market all of our three key autoimmune biosimilars to improve the lives of patients,” said Samsung Bioepis CEO Ko Han-sung.

Imraldi was filed for marketing approval in Korea last year and is being prepped for an FDA application in the U.S.

By Shin Chan-ok

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