Can Biosimilar Studies Be Conducted Solely In Healthy Volunteers?
Coherus refutes Apotex argument that Neulasta biosimilars must be studied in at least one patient population. Its application could face delay as no advisory committee meeting has been scheduled ahead of its June 9 user fee date.
You may also be interested in...
Apotex argues that biosimilar studies in healthy volunteers are not sufficient to show clinically meaningful differences with the reference product; Coherus says it believes its application is scientifically sound.
High court set to determine timing of biosimilar marketing and how parties handle patent disputes in Sandoz v. Amgen. Stakeholders say the outcome will impact innovation, access to biosimilars and future litigation.
Sandoz needs to do another study to satisfy FDA, while Amgen says it faces a slow pace of patent litigation with AbbVie.