According to a report on the Bloomberg web site earlier today, the U.S. Food and Drug Administration (FDA) is close to approval of a truly biosimilar formulation of Amgen’s Neupogen®, which is widely used in the treatment of patients with cancer and a low white cell blood count.
This biosimilar formulation of Neupogen, developed by Novartis, is stated by an FDA report to meet
… the requirement for a demonstration of “no clinically meaningful differences” between the proposed product and the reference product in terms of safety, purity, and potency …
The question of whether physicians and patients will be willing to embrace the prescription and use of this and other biosimilars is rather more complex. Prior (branded) biosimilar compounds — all of which had to actually prove effectiveness and safety in clinical trials (as opposed just proving biosimilarity) have been far from successful in eliminating the market stature of original, innovator compounds.
We’re going to have to wait and see what actually happens … first with regard to the actual FDA advisory meeting on January 7 this week, and then with regard to how successful Novartis can be at “moving product” into clinical practice.