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

The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases.

A decision in favor of approval had been expected after the FDA’s advisory panel voted 20-0 in support of Novartis’ biosimilar. The product is a biosimilar to etanercept (Enbrel, Amgen), which was originally licensed in 1998.

Erelzi is the second biosimilar from Sandoz approved in the U.S. through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.

Erelzi is the second biosimilar successfully developed by Novartis’ Sandoz unit, which hopes to launch five biosimilars of major cancer and immunology drugs by 2020.

Yet Erelzi remains stuck in the starting blocks because USA courts have ruled makers of biosimilars must wait 180 days after winning FDA approval before beginning sales of the near-copies. A biosimilar product is a biological product that is approved based on a demonstration that it is highly similar to an already-approved biological product with no clinically meaningful differences in safety and efficacy from the reference product.

A marketing application for Sandoz’s biosimilar etanercept has been accepted by the European Medicines Agency (EMA) and is now undergoing review, with a decision expected before the end of the year.

Generally, biological products are made of a living organism and can belong to numerous sources, such as animals, humans, yeast or microorganisms. It should not be administered to patients with sepsis.

Like Zarxio and Inflectra, the US FDA has deemed Erelzi biosimilar but not interchangeable, meaning it may not be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product. Included are the same boxed warnings about risks of serious infections and certain hematologic malignancies also carried on etanercept’s label. Still, the green light continues the positive signaling from the agency on continued development of biosimilar drugs. The target, Enbrel, is Amgen’s biggest drug with $5.36 billion in sales previous year.

Sandoz is a Novartis company. More recently, Novartis received a rejection letter from the FDA for its biosimilar to Neulesta.