Apotex Canada received its first Biosimilar registration in Europe of Amgen’s blockbuster cancer treatment filgrastim!
Apotex’s version of filgrastim received regulatory approval from the European Commission.
Out-of-patent filgrastim, a biologic drug branded as Neupogen by Amgen and as Grastofil by Apotex, is used to boost production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy.
The product will be marketed by Stada in nearly all European Union countries. Stada plans to start sales next year, hoping to win a slice of the 1 billion euro ($1.4 billion) European filgrastim market.
Stada has been among the first European generics makers to invest in biosimilars, winning European approval for a version of aneamia treatment epo as early as 2007, but the business has so far failed to make meaningful contributions to group sales.