Novartis wins US OK for biosimilar version of Amgen's Enbrel

Henrietta Brewer
August 31, 2016

The follow-up version of Enbrel, dubbed Erelzi, was developed by Swiss drug giant Novartis, which would not disclose the planned list price for Erelzi.

US regulators on Tuesday approved the first lower-cost version of Enbrel, a blockbuster anti-inflammatory drug from Amgen that is among the top-selling drugs in the world. It can cost about $4,000 per month without insurance. Enbrel, which was first approved in 1998, is approved to treat rheumatoid arthritis and other conditions by decreasing the amount of a protein produced by the immune system. It is the third biosimilar approved in the U.S. Already available in Europe, the drugs have the potential to generate billions in savings for insurers, doctors and patients. Both companies refused to discuss how long that injunction will last. Under that timeline, a near-term launch of lower-cost Enbrel "is off the table", he states in a recent note to investors.

Amgen and Sandoz are still working on the details of when Erelzi will launch in court.

Erelzi is the second biosimilar approved via the Biologics Price Competition and Innovation Act in the U.S. from Sandoz (the first was for Zarxio (filgrastim-sndz), which is biosimilar to Amgen's Neupogen).

"The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases", Dr. Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research, said in a news release.

With sales of $5.3 billion previous year, the drug made up about 20 percent of Amgen's $21.6 billion in revenue. Amgen is trying to develop a biosimilar to Humira. Enbrel sales also increased 10 percent during the second quarter of 2016 to $1.4 billion.

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