Sandoz files for first FDA biosimilar approval under 351(k) biosimilarity rules

It’s a milestone, of sorts: Sandoz, the generics arm of Novartis, has announced that FDA has accepted its application for approving biosimilar filgrastim, the Amgen product marketed as Neuprogen for treating patients undergoing chemotherapy. Sandoz says that it is currently marketing the product in 40 countries outside the US. What happens next remains to be seen. FDA has issued multiple draft guidances about biosimilar approvals, most recently in May. The so-called 351(k) pathway for approval, authorized under the Biologics Price Competition and Innovation Act of 2010, indicates that FDA will look for a degree of biosimilarity, based on certain risk factors, but there remains no bright-line distinction between “similar” and “not so similar, but okay.”

Even after the scientific issues are resolved, significant policy issues remain. Sandoz has already branded its product as Zarzio, but that raises the question whether a physician will write a prescription for “Neuprogen,”, “Zarzio,” or “filgrastim,” and what happens after that. The Alliance for Safe Biologic Medicines (Arlington, VA), a very pointed trade group of branded biologics manufacturers, has been agitating for requiring a different name to be used for biosimilars, which could defeat the purpose of having them in the first place. The Alliance has convinced at least three state governments to pass laws requiring prescriptions to be filled as per how the prescription is written, and in a remarkable example of doublethink, applauds each state that does so for making biosimilars “available” to patients. For its part, the Generic Pharmaceutical Assn. is pushing for identical non-proprietary names (i.e., the generic name).

At stake is the 20-30% discount from the branded, originator drug price that is expected when biosimilars come on the market; all this is happening while new biologics entering the market represent a growing portion of overall drug costs; industry estimates put 2020 as the year when the biopharma industry will generate more revenue from biologics than from small-molecule drugs.