Celltrion’s Herzuma gets green light in CanadaCelltrion received approval to sell its bio similar Herzuma in Canada, the company said Tuesday.
Herzuma is a biosimilar which references Roche’s Herceptin - a breast cancer treatment that rakes in 8.7 trillion won ($7.3 billion) a year worldwide. The United States and Canada combined account for 40 percent of sales.
Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products.
The approval came after Health Canada confirmed that Herzuma’s safety and effectiveness was identical to the original product. The decision adds to the U.S. Food and Drug Administration’s approval of Herzuma last December.
Celltrion is currently at the stage of discussing launch details with its local distribution partner, Teva Pharmaceutical Industries.
With the latest Herzuma approval from Canada, all three of Celltrion’s biosimilars are now approved for sale in the United States and Canada.
BY SONG KYOUNG-SON [firstname.lastname@example.org]