April 26, 2024

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[THE INVESTOR] Twelve homegrown drugs have got approval from US and European health authorities for sale since 2003, including two treatments developed by SK Chemical and Samsung Bioepis that received the green light in January this year, according to the Korea Pharmaceutical Manufacturers Association on Feb. 7.

South Korean drug makers started to strengthen their presence in the two biggest pharmaceutical markets in full swing from 2014 with the government’s push to nurture the drug and biotech industries as the country’s next growth engine.

“Since LG Life Sciences won the FDA approval for its quinolone antibiotic Factive, the first for a Korean firm, local drug makers’ business expansion into the US and European markets have begun in earnest in 2014 and the trend is continuing this year,” said an official at KPMA.

Six treatments developed by Korean companies have been approved by the FDA to date, including three products -- Celltrion’s infliximab biosimilar Remsima, SK Chemicals’ hemophilia drug Afstyla and Daewoong Pharmaceutical’s Meropenem, a Carbapenem antibiotic.

SK Chemicals’ Afstyla is also set to enter the European market having got approval from the European Medicines Agency in January, when Samsung Bioepis’ diabetes medicine Lusuduna was also granted approval.

So far, a total of six medications have secured marketing authorization from the EMA.

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