The Ministry of Food and Drug Safety and Celltrion said rumors about the drugmaker giving up on the local release of HIV treatment Temixys (tenofovir disoproxil fumarate/lamivudine) were not true.
News reports had said Celltrion delayed the application for approval in Korea because the ministry asked the biosimilar maker to submit phase-3 local trial data. The company recently won the U.S. Food and Drug Administration’s green light for the HIV drug.
“We did not put off the application for Temixys approval. We are smoothly discussing with the food and drug safety ministry about procedures to win the license,” an official at Celltrion said.
The ministry also denied news reports that claimed local regulations made it difficult to obtain drug license because they were stricter than those in foreign countries.
“Korea is the sixth country to join the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) after the U.S., European Commission, Japan, Switzerland, and Canada. The food and drug ministry’s standards for drug approval review are equal to those of the U.S. FDA,” the ministry said.
As Celltrion’s Temixys is a combination drug, mixing lamivudine (for inflammation) and tenofovir disoproxil fumarate (for HIV), the company needs to submit data not from a phase-3 trial but a clinical pharmacology study that compares bioavailability. This is the same regulation as the U.S. one, it added.
The ministry also explained it was not true that Celltrion did not receive the nod for antibiotic Linezolid generic because of the local regulations on bioequivalence test, whereas it obtained the nod from FDA.
“Celltrion won the local license for linezolid-containing generic drug Mycovox Tab. on Feb. 7, 2018,” the ministry said.
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