has sought approval from Japan’s Health Ministry for its biosimilar drug Herzuma, with aims to start sales in 2018. the Korean biopharmaceutical firm said on April 13.
Herzuma’s reference drug is Roche’s Herceptin, a blockbuster breast cancer drug that generated revenue of 450 billion won (US$396 million) in Japan -- which accounts for one-third of the Asia-Pacific biologics market. Globally, the drug generated US$6.8 billion revenue in 2016.
“We don’t see too many hurdles, as we already have the expertise, and also experience of selling Remsima in Japan,” Celltrion CEO Kim Hyoung-ki told The Investor.
Its antibody biosimilar Remsima, a copycat version of Johnson & Johnson’s top med Remicade, hit Japanese shelves in 2014.
Celltrion’s distribution partner Nippon Kayaku has exclusive rights to commercialize both Herzuma and Remsima in Japan.
“We are closely cooperating with our Japanese partner for Herzuma’s successful launch in Japan ahead of entry into other global markets including Europe,” Celltrion said in a statement.
According to the Korean pharma giant, Japan is moving to reform its health care policies to facilitate the introduction of biosimilars -- cheaper, near replicas of the original living cell-based biologic drugs -- as its health insurance finances are faltering in the face of snowballing costs for elderly care. This is expected to have a positive impact on expanding the market share of Herzuma.
Along with Celltrion, Samsung Bioepis and US-based firms Mylan and Amgen have also developed biosimilars of Herceptin. The four firms have filed for sales approval from the European Medicines Agency.
By Park Han-na (firstname.lastname@example.org)