The FDA Aug. 30 approved Novartis AG's biosimilar version of Amgen's arthritis drug Enbrel.
The product from Novartis's Sandoz unit, called Erelzi (etanercept-szzs), is the third biosimilar drug to receive approval from the Food and Drug Administration. The Affordable Care Act created an abbreviated pathway for the FDA to approve biosimilars. While three biosimilars have been approved, so far the agency hasn't approved any drugs meeting the higher standard of interchangeability.
Sandoz noted in a statement that Erelzi is approved for all indications included in the label of the reference product, Enbrel.
In March 2015, the agency approved Sandoz's Zarxio, a biosimilar of Amgen's cancer treatment Neupogen. In April 2016, the agency approved Celltrion's Inflectra, a biosimilar of Johnson & Johnson's blockbuster arthritis treatment Remicade.
Biological products are generally derived from a living organism, the FDA said. A biosimilar is a biological product that is approved based on a showing that it is highly similar to an already approved biological product and has no clinically meaningful differences in terms of safety and effectiveness from the reference product, in addition to meeting other criteria specified by law.
An interchangeable biological product, in addition to meeting the biosimilarity standard, is expected to produce the same clinical result as the reference product in any given patient, according to the FDA.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)