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5 January 2015Americas

FDA gives nod to Novartis cancer biosimilar

The US Food and Drug Administration (FDA) has recommended that an application by pharmaceutical company Novartis to market a biosimilar version of Amgen’s cancer drug Neupogen (filgrastim) be approved.

In a report published today (January 5), FDA reviewers said they had found no “clinically meaningful differences” between the Novartis biosimilar and Amgen’s original version, and that the application should be approved.

“Taken together in considering the totality of the evidence, the data submitted by the applicant show that EP2006 [the proposed biosimilar] is highly similar to US-licensed Neupogen and the clinical data have shown that there are no clinically meaningful differences between EP2006 and US-licensed Neupogen …” said the report.

The FDA reviewers recommended that Novartis's copy should be approved for all five indications for which Neupogen is approved, they said in their report, whose recommendations will be considered at a meeting on January 7.

Neupogen, developed by pharma company Amgen, is used to help increase the white cell blood count of cancer patients.

Novartis’s generic arm Sandoz sells copies of the drug under the brand name Zarzio in more than 40 countries but has not yet marketed it in the US.

Last year, LSIPR reported that an initial Novartis application for a biologics licence application in the US had been accepted.

It was then left to FDA reviewers to detect any defects or ask questions about the clinical and manufacturing test data before deciding on approval.

Biologics are made from living cells. The system for allowing them in the US was created by the Biologics Price Competition and Innovation Act, implemented in March 2010.

According to a report from business research company Allied Marketing Research, worldwide sales for biosimilars, which mimic biologics, will reach $35 billion by 2020.


More on this story

Americas
29 July 2014   US officials have accepted an application by Novartis to market a biosimilar of Amgen’s Neupogen (filgrastim) drug, a move thought to be the first of its kind.
Biotechnology
26 July 2021   A California jury has ordered Novartis to pay $178 million to rival drugmaker Daiichi Sankyo for willfully infringing two cancer drug patents.

More on this story

Americas
29 July 2014   US officials have accepted an application by Novartis to market a biosimilar of Amgen’s Neupogen (filgrastim) drug, a move thought to be the first of its kind.
Biotechnology
26 July 2021   A California jury has ordered Novartis to pay $178 million to rival drugmaker Daiichi Sankyo for willfully infringing two cancer drug patents.