New administration route for Sandoz' Binocrit biosimilar approved in EU

Sandoz, the generics and biosimilars business of Swiss pharma giant Novartis (NOVN: VX), has received approval from the European Commission (EC) for a type II variation for the addition of a subcutaneous (sc) route of administration in Binocrit’s(epoetin alfa) nephrology indication.

Binocrit is a biosimilar of Amgen’s Epogen, and Sandoz says its epoetin offering has already generated more than 400,000 patients years of experience worldwide. Amgen’s sales of the drug are falling due to competition, but still came in at $1.86 billion in 2015.

“By expanding our biosimilar offering to the healthcare community, the EC approval of a subcutaneous route of administration for use in our Binocrit’s nephrology indication will mean more choice for healthcare professionals as well as increased convenience for patients,” said Carol Lynch, global head Biopharmaceuticals, Sandoz.