Korean biosimilar makers are making strides toward a high-end pharma market in Japan, bringing the number of locally available Korean-made biologics to five in total.

Dong-A ST and ChongKunDang are the latest players on the list with Darbepoetin-α BS and Nesp Prefilled Syringe, respectively, which are biosimilar versions of Nesp used to treat anemia in patients with chronic kidney disease or those who receive chemotherapy. Nesp is a global blockbuster drug with $3 billion in worldwide sales and $456 million in Japan alone.

Celltrion’s Remsima is the first Korean biosimilar that entered the world’s third largest pharmaceutical market upon gaining marketing approval in Japan 2014. In 2018, Celltrion launched another biosimilar Herzuma, while LG Chem got the nod for its rheumatoid arthritis drug Eucept.

Celltrion’s third biosimilar Truxima is in regulatory review in Japan. CJ Healthcare signed an out-licensing deal with Japan’s YL Biologics (YLB) over the former’s anemia drug CJ-40001 which is being evaluated in a phase 3 trial in Japan.

Korean biopharmas are turning their eyes to Japan’s biosimilar market as demand for more affordable treatment options gradually increase due to the population aging and high healthcare budget.

However, some express concerns that there are limitations for Korean pharmaceutical and biotech companies to make meaningful profits in Japan, notoriously defensive against foreign brands. Korean companies also have to compete with global pharma giants that are already present in the market. Samsung Bioepis has not entered the Japanese biosimilar market because it believes the opportunity cost is too high in Japan.

Market research firm BMI Research forecasts Japan’s pharmaceutical market will be valued at $111 billion this year.

By Kim Si-gyun and Minu Kim

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