Sandoz, a subsidiary of Swiss Biopharma Novartis, received US Food and Drug Administration (FDA) approval for Zarxio - its copycat version of Amgen’s Neupogen - in March. The product is, as of today, available in the US, becoming the first biosimilar to be launched in the world’s largest market.
The launch was originally set for Wednesday after the US Court of Appeals for the Federal Circuit ruled against Amgen’s attempts to block the drug in July. However, a second appeal proved ineffective with the Court yesterday rejecting Amgen’s appeal two to one, allowing Sandoz to proceed with the launch.
“Sandoz has maintained a commitment to bringing high-quality biosimilar medicines to patients and healthcare professionals around the world,” said Richard Francis, Global Head at Sandoz. “With the launch of Zarxio, we look forward to increasing patient, prescriber and payor access to filgrastim in the US by offering a high-quality, more affordable version of this important oncology medicine.”
15% Cost Saving
A Sandoz spokesman told Biopharma-Reporter the firm's approach for marketing biosimilars "is much closer to the approach for a branded product than that of generic medicine, and as such Sandoz has a fully integrated commercial organization behind the launch of Zarxio."
As to the cost, he said the WAC (Wholesale Acquisition Cost) for a Zarxio 300 mcg/0.5 mL prefilled syringe is $275.66 (€245), and $438.98 for Zarxio 480 mcg/0.8 mL. Equivalent dosage forms and strengths of Neupogen cost $324.30 and $516.45, respectively, according to an Amgen spokesperson.
This 15% saving falls in the lower end of the discount set out in initial guidelines on biosimilar pricing put forward by the US Centers for Medicare and Medicaid Services (CMS) earlier this year.
This milestone marks a new era in the US biopharma market, and Zarxio’s uncharted entry could mark out the way for a number of other copycat biologics. Other biosimilars under review by the FDA include Apotex’s version of Neupogen, Hospira’s copy of Amgen’s Epogen, and Celltrion’s version of J&J’s mAb Remicade.
A decade on from Europe
But the US breakthrough comes almost a decade after the first biosimilars were approved in Europe (Sandoz’s Omnitrope and Biopartners’ Valtropin received the regulatory tick in April 2006), and there remains a number of unanswered questions as to the substitution and naming of such products.
Zarxio’s non-proprietary name is filgrastim-sndz, under FDA draft guidelines officially proposed last week determining such products must have a four-letter suffix to distinguish biological and biosimilar products. Neupogen is therefore known as filgastrim-jcwp in its license.
Furthermore, Zarxio has not been approved as an interchangeable biosimilar by the FDA as despite demonstrating biosimilarity in its submission through the 351(k) pathway, it did not include interchangeable data.
This in effect restricts Zarxio being substituted for the reference product without the intervention of the prescribing healthcare provider, despite the product being approved for the same indications as Neupogen.