SK Biopharmaceuticals’ epilepsy drug cenobamate, the first FDA-approved drug independently developed by a Korean company, brings renewed attention to other homegrown brands tapping the world’s largest pharmaceutical market.
HLB is among the Korean listed companies in the healthcare sector whose commercial development in the U.S. nears completion next year. The manufacturer-turned-biotech company released global phase 3 trial data of targeted cancer drug rivoceranib and has already finished a pre-NDA meeting with the Food and Drug Administration on Oct. 24.
The company plans to submit an application late April next year for FDA’s guidelines. Given six to eight months in the FDA’s review period for an orphan drug like rivoceranib, marketing authorization is expected at October or December 2020.
Mezzion Pharmaceuticals is preparing to file a new drug application with the FDA after its release of phase 3 data of heart disease treatment udenafil on Nov. 18. Mezzion said it has received positive signals for its BLA for the drug that can be used to improve exercise capacity in adolescents with congenital single ventricle heart disease. Given its orphan drug status, it could be approved as early as the second half of next year, according to the company.
Helixmith, a company that is developing diabetic neuropathy drug Engensis, aims to file an application in the second half of next year after completing a phase 3-2 trial whose data will be added to earlier results.
Biosimilar pipeline in the U.S. from Korea is also packed. Celltrion said it will launch Herzuma, a biosimilar to treat breast cancer, in the first quarter of next year, after Truxima, its biosimilar to treat blood cancer, was launched this month in the U.S. Samsung Bioepis filed for the FDA approval for SB8, a biosimilar version of reference oncology drug Avastin this month. Marketing is expected to be possible a year later. SB8, if approved, will be the company’s fifth biosimilar in the U.S. market.
Hanmi Pharmaceuticals hopes to join the market as it refilled for the FDA approval for its neutropenia drug Rolontis last month. Neutropenia, an abnormally low concentration of neutrophils in the blood, is often caused by cancer treatment or infection. In 2012, Hanmi Pharm signed a licensing agreement with Spectrum Pharmaceuticals, giving the global rights for Rolontis. Spectrum said it submitted an expanded BLA to the FDA based on robust clinical data from two large pivotal independent randomized controlled trials. Hanmi Pharm is also working on oral cancer drug Oraxol for the FDA NDA filing next year.
By Kim Byung-ho, Seo Jin-woo and Minu Kim
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