Apotex Urges the FDA to Require Testing of Biosimilars on Intended Patient Population
Apotex has called on the FDA to require testing on the intended patient population before approving biosimilars.
Specifically, the company cites an August 2016 application by Coherus Biosciences for a biosimilar of Amgen’s Neulasta — a bone marrow stimulant for patients undergoing cancer treatments — based on data from a clinical trial involving only healthy patients.
Apotex has submitted its own biosimilar BLA for Neulasta, including comparative efficacy data from patients with breast cancer.
The requirement for biosimilars to demonstrate “no clinically meaningful differences” means proposed biosimilars must feature a study population representing the intended response, Apotex says.