Dong-A ST Signs License-Out Agreement for Biosimilar 'DA-3880' with Turkish Pharmaceutical Company

[Asia Economy Reporter Lee Gwan-joo] Dong-A ST announced on the 7th that it has signed an exclusive license-out and supply agreement for the second-generation anemia treatment Darbepoetin-α biosimilar 'DA-3880' with the Turkish pharmaceutical company Polifarma.

According to the contract, Dong-A ST will transfer the exclusive development and sales rights of DA-3880 in Turkey, Brazil, and Mexico to Polifarma. Dong-A ST will receive an upfront payment and milestone payments at development and commercialization stages, and will be responsible for exclusive supply of the finished product.

After commercialization, production will be handled by STGen Bio, a contract development and manufacturing organization (CDMO) specialized company within the Dong-A Socio Group. Polifarma will be responsible for clinical development, approval, and sales of DA-3880 in Turkey, Brazil, and Mexico. The upfront payment, milestones, and sales revenue from supply were decided to remain confidential by mutual agreement between the two companies.

'DA-3880' is a biosimilar of the second-generation anemia treatment Nespo, used for treating anemia in chronic kidney disease patients and anemia caused by chemotherapy. After signing a license-out agreement with Japan's Sankyo Chemical Research Institute (SKK) in 2014 for the development and sales of DA-3880 in Japan, it obtained manufacturing and sales approval in Japan in 2019, achieving sales of 8 billion KRW in 2020 and 12.5 billion KRW in 2021, and is regarded as having successfully established itself in the Japanese biosimilar market.

Polifarma is a Turkish pharmaceutical company with a global sales network in over 50 countries. It has expanded into the United States, Europe, Brazil, Mexico, and exports more than 500 pharmaceutical products, accumulating approval experience.

Jae-hong Park, Head of R&D at Dong-A ST, said, “Through this contract, we have created an opportunity for DA-3880 to expand beyond the Japanese market into the global biosimilar markets of Turkey and Latin America. We will continue to showcase Dong-A ST’s biopharmaceutical R&D capabilities and global business development skills to expand the number of countries we enter worldwide.”