[THE INVESTOR] Korean pharmaceutical firm Dong-A ST said on Oct. 1 its co-developer Sanwa Kagaku Kenkyusho has sought approval from the Japanese health regulator for its biosimilar version of Amgen’s red blood cell booster Aranesp.

If its Japanese partner gets the approval, Dong-A ST will export the finished drug product to SKK, which will be in charge of distribution in the country. 

The drug candidate DA-3880 is a copy version of Aranesp, co-developed by Kyowa Hakko Kirin and Amgen, a treatment of anemia associated with chronic renal failure or caused by chemotherapy.

“The Japanese biosimilar market is expected to increase significantly due to the growing needs for medical expense deduction as the country is inching closer toward a super-aged society,” a Dong-A ST official said.

Last year, sales in Japan contributed US$439 million to Aranesp’s US$3 billion in global sales.

It typically takes about 12 month to receive marketing approval from Japan’s Ministry of Health, Labor and Welfare, the Korean company said.

Since the Korean drug maker out-licensed DA-3880 to SKK in 2014, the Nagoya-based firm has been conducting phase 1 and 3 clinical trials to prove that its version has equivalent effectiveness and safety as the original biologic.

There are two more Korean companies that are developing their biosimilars referencing Aranesp and targeting the lucrative Japanese market. Chong Kun Dang’s CKD-11101 is expecting the Korean drug regulator’s green light within this year. It sold its Japanese license to a US CJ-40001 pharmaceutical company in April.

CJ Healthcare had signed a license deal with Tokyo-based biopharmaceutical firm YL Biologics to export its version CJ-40001 in September last year.

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