In terms of the discount that Sandoz will provide on the biosimilar, Sandoz spokeswoman Elizabeth Renz told Focus: “It is too early to speculate about the price of Erelzi”.
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Importantly, the FDA okayed Erelzi for use across all five of Enbrel’s approved indications.
Made by Switzerland-based Novartis, Erelzi mimics the effects of Enbrel. Still, the green light continues the positive signaling from the agency on continued development of biosimilar drugs.
“We are committed to bringing Erelzi to the USA market as soon as possible”, said Carol Lynch, global head of biopharmaceuticals at Novartis’ Sandoz unit in Germany. Sandoz, the generics arm of the Swiss pharma giant, also won approval for a copy of Amgen’s Neupogen a year ago.
“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases”, Janet Woodcock, MD, director of the agency’s Center for Drug Evaluation and Research, said in the news release.
Erelzi is the second biosimilar approved via the Biologics Price Competition and Innovation Act in the United States from Sandoz (the first was for Zarxio (filgrastim-sndz), which is biosimilar to Amgen’s Neupogen). “Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product”.
Erelzi should not be administered to patients with sepsis.
So far none of the three biosimilars okayed by the FDA have been classified as an interchangeable.
The FDA today approved Erelzi, a biosimilar to etanercept (Enbrel), for all the indications included in the labeling of the reference product, according to manufacturer Sandoz.
Erelzi contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, invasive fungal infections (such as histoplasmosis) and others.
With sales of $5.3 billion past year, the drug made up about 20 percent of Amgen’s $21.6 billion in revenue. Sales of Enbrel account for about 25% of the company’s total sales. This drug was a knock off of another treatment from Amgen, Neupogen, for neutropenia.
Generic drugmakers have typically operated as distinct from their branded counterparts, although the lines have blurred in recent lines.
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Assuming the USA follows the scenario unfolding in Europe – where biosimilars have been available for a decade with more than 20 products approved to date – it is expected that new biosimilar launches will be priced at a 30-50% discount to the originator brand.
