Long-Anticipated Biosimilar From Novartis Launched, but at What Price?

Approved by the FDA in March 2015, Zarxio (filgrastim-sndz) has finally entered the US market as the first biosimilar. Amgen, the company manufacturing the reference product Neupogen, saw its last-ditch effort to stop marketing of Zarxio stalled by a federal appeals court on Wednesday, with the rejection of a request for a temporary injunction to block Novartis from selling Neupogen.

Developed by Sandoz as a biosimilar to Amgen’s Neupogen, Zarxio is a leukocyte growth factor that can provide an immune boost to the body and is indicated in patients with cancer receiving myelosuppressive chemotherapy.

An important piece of the puzzle—the cost of the drug—was solved today, with the announcement that the biosimilar would be sold at 15% lower cost compared with the reference product, Neupogen. Stakeholders have argued that a biosimilar product cannot be equated to a generic product and therefore, may not necessarily yield the cost savings seen with generic drug moieties. However, Zarxio could well be a case study to determine the route that the next wave of less expensive biosimilars take with respect to regulatory approval, cost, and provider uptake.

Novartis said the US wholesale list price for a 300 microgram syringe of Zarxio was $275.66, with the 480 microgram version costing $438.98. Neupogen costs $324.30 and $516.45 for the same syringe formulations, according to Amgen. These numbers are important for insurance companies to consider. Nearly 50% of Aetna’s drug spending for example, is on specialty products used by just 1% of its customers. Now, more than ever, biologicals and their prices have been a cause for concern with extremely effective antibodies to treat cancer, rheumatoid arthritis, and cholesterol flooding the market. Physicians, health plans, and pharmacy benefit managers are all taking a firm stand against these high-price drugs and biosimilar products may well be the answer.