October 2, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Novartis announced today that the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for its proposed biosimilar to Amgen ’s Enbrel (etanercept).
A biosimilar is a drug that acts the same way as a known drug, but has at least a few molecular differences, in order to differentiate it from the branded drug. Their approval was part of the Affordable Care Act, specifically the Biologics Price Competition and Innovation Act, and was intended to increase competition for expensive drugs, presumably to drive the price down for consumers.
Enbrel is a tumor necrosis factor alpha (TNF-alpha) inhibitor, which is used to treat a variety of autoimmune diseases, including rheumatoid arthritis and psoriasis.
Sandoz, Inc., a division of Novartis, submitted the BLA using the 351(k) biosimilar pathway, which is made up of data from analytical, functional, pre-clinical and clinical studies. Sandoz has performed two pivotal clinical studies, a pharmacokinetic (PK) study in healthy volunteers and a confirmatory safety and efficacy study in patients with psoriasis.
“Anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines,” said Mark McCamish, head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz in a statement. “We believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept.”
Enbrel is sold by Amgen in the U.S., and outside the U.S. by Pfizer Inc. . The drug had sales of $9 billion last year, which makes it the world’s fifth bestselling drug. Merck & Co. and Samsung Bioepis have received approval for biosimilars of Enbrel in South Korea. Samsung and Biogen, Inc. are attempting to get approval for biosimilars to the drug in Europe.
On Sept. 3, 2015, Sandoz announced that its biosimilar, Zarxio (filgrastim-sndz), the first biosimilar approved by the FDA, was to launch in the U.S. Zarxio is a biosimilar to Amgen’s Neupogen. Zarxio’s non-proprietary name is filgrastin-sndz, which has a four-letter suffix per FDA draft guidelines to distinguish them from their biological (as opposed to biosimilar) products.
Zarxio is not approved as an interchangeable biosimilar, however. Although it has shown biosimilarity via the 351(k) pathway, the data was not interchangeable. Basically this means that there are restrictions on Zarxio being substituted for its reference product, in this case, Neupogen, unless the physician prescribing the drug intervenes. According to Biopharma-Reporter, Zarxio is selling for about 15 percent less than Neupogen.
Reuters notes that insurance providers and government healthcare systems “hope biosimilars will cost the public 40 percent to 50 percent less than the original drugs and experience in Europe suggests that steep discounts are being offered in some markets.” Europe has been allowing biosimilars since 2007.
It’s also noted that although insurers and the public seem positive about biosimilars, investors have concerns about how these copycat products will affect company profits. A study published in American Health Drug Benefits noted that, “Various factors, such as safety, pricing, manufacturing, entry barriers, physician acceptance, and marketing, will make the biosimilar market develop different from the generic market. The high cost to enter the market and the size of the biologic drug market make entry attractive but risky.”
“We are confident in our Enbrel patent positions, extending to 2029,” said Amgen. “We will seek to enforce our patent rights, in litigation against Sandoz if necessary, as directed by the provisions of the biosimilars statute.”
