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11 Mar 2015

FDA approval of 1st biosimilar cancer drug

On Friday, FDA approved Zarxio, Novartis AG’s version of Amgen’s biologic drug Neupogen, making it the first biosimilar medication approved by USFDA.

Novartis is already selling the biosimilar in more than 40 countries.

Neupogen is used to lower the rate of infections in cancer patients undergoing chemotherapy. In July 2014, FDA accepted an application from Sandoz — a subsidiary of Novartis — seeking approval for its biosimilar of Neupogen, marking the first time the agency agreed to consider approval for a biosimilar.

Approval Details
FDA approved Zarxio for all the same uses as Neupogen, and the agency said the drug could use nearly identical language on its label as the brand-name version.

Overall, FDA said Zarxio and Neupogen have “no clinically meaningful differences”.

FDA named the drug filgrastim-sndz, which includes the generic name for the Neupogen and a suffix that stands for Sandoz, the manufacturer.

The decision is significant because some generic drugmakers and insurers want the biosimilars to carry the same generic name as the brand-name product, while some biologic manufacturers argue that the name should be different to facilitate tracing a drug’s side-effects to the drugmaker.

However, it is not yet clear how much other biosimilar treatments could cost, and Zarxio’s cost will not be announced until the drug is put on the market. Novartis so far only has indicated that the drug will be “competitively priced.” By contrast, one dose Neupogen can cost between $315 and $500.

Overall, biosimilars available in Europe generally cost between 15% and 30% less than their brand-name counterparts.

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