COPENHAGEN, Sep 3 (Reuters) - Danish group Novo Nordisk , the world’s biggest insulin producer, could see its insulin degludec launched in Japan this year, analysts at Nordea said, after the product passed an initial review in the country.
The First Committee on Drugs of Japan’s Pharmaceutical Affairs on Friday passed the review of degludec on Friday.
That meant the long-acting insulin, expected to be launched under the name Tresiba, could also be approved both in the European Union and the United States, Nordea said in a note to clients.
“After subsequent price negotiations, a launch could take place in 2012, in our view ... we have assumed a launch in Japan in 2013,” Nordea said.
The First Committee on Drugs serves as an advisory body to the Ministry of Health, Labour and Welfare, and the remaining step in the regulatory process will be an official approval from the ministry, Novo Nordisk said.
“We think there is very good read-across to both EU and the U.S. regulatory processes,” Nordea said.
It said it expected to receive marketing authorisation from the ministry within a few months and insulin degludec would be launched shortly after completion of subsequent price talks. (Reporting by Mette Fraende; Editing by Dan Lalor)