Daewoong Pharmaceutical said its liver drug Ursa was likely to become the company’s third medicine to be sold in the U.S.
The Korean drugmaker said it recently finished a bioequivalence test on the hepatic protector’s ingredient ursodeoxycholic acid (UDCA) in Canada.
The completion of the test came in four months after Korea Biomedical Review reported on Daewoong’s attempt to sell Ursa in the U.S. in December.
With the clinical results of the test in Canada, Daewoong plans to apply for the nod of the U.S. Food and Drug Administration (FDA) as early as this year, the company said.
If Ursa wins FDA approval, Daewoong will be able to sell three drugs in the U.S., including antibiotics Meropenem and botulinum toxin Nabota. Ursa’s main ingredient UDCA is contained in Urso, Ursa’s control drug by Forest Labs. Urso obtained U.S. approval in 1997.
Daewoong said Ursa’s winning the U.S. greenlight would boost the drugmaker’s sales in the U.S. The UDCA market in the U.S. is estimated to be around 1 trillion won ($926.4 million) and there are three Ursa generic drugs.
Despite high entry barriers, Daewoong has high expectation for Ursa because the U.S. has a large UDCA market and there are few rivals for Ursa.
In Korea, UCDA drugs are prescribed at a maximum dose of 600mg per day. However, in the U.S., the maximum dose is set at 900-1,200mg.
“Our bioequivalence test was successful. We will apply for the FDA approval in the second half. We will be able to release Ursa next year at the earliest,” a Daewoong official said.
In November, Daewoong received the FDA’s inspection on its plant in Hyangnam, Gyeonggi Province, as a preparation for the U.S. market entry.
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