April 27, 2024

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[THE INVESTOR] Samsung Bioepis is expected to gain approval to commercialize its copycat version of AbbVie‘s blockbuster drug Humira in Europe later this year as its biosimilar has cleared a key regulatory hurdle.

Imraldi, monoclonal antibody treatment developed by the company, was recommend for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency on June 24. 

“The endorsement brings us a step close to delivering a lower-cost, high-quality autoimmune treatment option to patients across Europe,“ CEO Ko Han-sung said in a statement.

After receiving positive opinion from the committee, it normally takes two to three months for the European Commission to give the final nod to sell drugs.

Samsung Bioepis originally submitted the biosimilar candidate referencing Humira, which clocked in sales for AbbVie of over $16 billion worldwide last year, for approval in the European Union in June 2016.

If Imraldi is now approved by the EU it will be the fourth biosimilar success for the Korean company, following approval for selling its own versions of Remicade and Enbrel in 2016.

The drug becomes the second version of Humira to be given a positive opinion by the EMA after the CHMP recommended Amgen’s Amgevita in January. It won EMA approval in May.

Meanwhile, Samsung Bioepis is preparing to file an application for regulatory approval of Imraldi in the US. It sought permission from Korea’s Ministry of Food and Drug Safety in August 2016.

By Park Han-na (hnpark@heraldcorp.com)