- The first biosimilar medicine ever approved in Turkey

- Approximately 24 billion KRW in exports forecast for the next five years

- A bridgehead established for advancement into EU markets



Dong-A Pharmaceutical has started exporting Leucostim, a treatment for neutropenia with granulocyte colony-
stimulating factor (G-CSF) as an active ingredient, to Turkey. Dong-A of South Korea entered into an agreement
with DEM Ilac Pharmaceuticals of Turkey in 2006 to the effect that the former would export 20 million USD in
Leucostim over a period of five years to the latter. The two companies then sought to obtain product registration
approval in Turkey, and the Turkish authorities approved Leucostim in September this year. Leucostim is the
first biosimilar medicine ever registered and marketed in the Turkish drug market.



The approval by the Turkish authorities, which observe guidance documents by the European Medicines
Evaluation Agency (EMEA), demonstrates Dong-A’s technological prowess and high product quality to
European drug markets of which good manufacturing practice (GMP) levels are advanced, raising potential
and expectations for additional revenues in other markets in the future.



The appropriate niche of the drug market in Turkey is estimated at 35 billion KRW and is dominated by
Neupogen from Roche. Dong-A is planning to increase its revenues and market share through effective
marketing in the wake of Leucostim’s registration as the first-ever biosimilar medicine in the country.
Meanwhile, early this October, the drug was introduced at the 35th National Haematology Congress (35. Ulusal
Hematoloji Kongresi), which was held in Antalya, Turkey, and it garnered great interest and positive response.




Dr. Hakverdi DEMIR, the representative director of DEM Ilac Pharmaceuticals, says, “Leucostim is {highly}
appreciated as it is the first biologic produced in East Asia in accordance with the EU guidelines for biologics.
Dong-A should grow rapidly since it has entered the Turkish biologic market faster than others through this
opportunity.”



Dong-A Pharmaceutical has exported biologics to such regions and countries as Southeast Asia, Latin
America, and India since the 1990s. In 2007, the leading Korean drug company generated about 45 billion KRW
in annual sales in biologics, proving the bright prospects for its biologics business. In particular, in the past
three years, Dong-A inked biologics exports agreements worth 80 million USD with drug companies in such
countries as Russia, Turkey, and Thailand, spurring biologics exports. The list of the exports includes
Gonadopin, which is a treatment for infertility.



Active in developing biologics since the 1980s, Dong-A provides a range of protein-based therapeutics,
including Eporon (hematopoietic agent), Growtropin (growth hormone), Leucostim (treatment for neutropenia),
and Gonadopin (treatment for infertility), as well as interferon α (antineoplastic agent). Through continued R&D,
it has accumulated basic technologies in a variety of areas, for example, technologies to culture animal cells,
to stabilize and keep proteins intact , to produce genetic medicine, and to test biologics. The company recently
developed new technology in tandem with the global trend of using serum-free media in cultivation of animal
cells. It is now focusing on research on medicines of slow release or sustained release, which are deemed to
be second-generation protein-based therapeutics. Moreover, Dong-A is proceeding with clinical trials for nine
more biologics to be launched in 2013.



The global biologics market, which was as large as 112.3 billion USD in 2007, is expected to reach 309.0 billion
USD by 2015, when the biosimilars market is expected to hit 60 million USD.