The approval of Ruxience (rituximab-pvvr) (Pfizer) a biosimilar for the originator product Rituxan (Genentech) brings the total number of FDA approved rituximab biosimilars to three. However, this latest entrant has the most approved indications including CD-20 positive CLL in combination with fludarabine and cyclophosphamide (FCR). At this point because of patent litigation, none of the currently approved products are available for distribution.
Biosimilars are complex biologically derived compounds that have been engineered to provide the same efficacy/safety profile as the originator product. Biosimilars are not like generic drugs in that at present they are not designated by the FDA as “Interchangeable”. In order to be classified as “Interchangeable”, the biosimilar would have to be approved for all the indications for the originator product. To date, no biosimilar maker has applied for the exact same indications as the originator.
As a practicing pharmacy executive, working in the oncology space, Rituximab is always on my Top 10 list of drugs with regard to cost. Based on my experience with having gained approval from the medical staff for biosimilar products at two major cancer centers, we have seen a reduction in price of 20-30% that we can then pass on to our patients and those who pay for their care. Biosimilars are expected to mute the rapid growth in drug spend at least for the foreseeable future.
Thomas E Henry III, MBA, RPh, CPh
Executive Director of Pharmacy (interim)
Roswell Park Comprehensive Cancer Center