Novartis, through Sandoz, already manufactures a biosimilar version of Amgen's NEUPOGEN, selling it under the brand Zarzio on more than 40 countries. It has not been approved for distribution in the United States yet but that could change, with the Food and Drug Administration giving Novartis' biosimilar filgrastim glowing remarks after a review.
The FDA has already approved Teva Pharmaceutical Industries Ltd's copy of NEUPOGEN in 2012 but as it is not a biosimilar, Novartis' Zarzio is still well on its way to being the first biosimilar to be approved in the country. Biosimilars, generic versions of biologic drugs, are not widely available in the U.S. because regulations have only recently been implemented, determining standards for safety and efficacy.
Like NEUPOGEN, Zarzio is designed to prevent infections in patients with breast cancer who are receiving chemotherapy. Treatment also kills off white blood cells, reducing their number which generally puts the body at increased risk. Having abnormally low white blood cells results in a condition referred to as neutropenia.
Novartis submitted its application back in July 2014. Its version of filgrastim was the first biosimilar to be reviewed in the country, referred to as EP2006 in FDA documents.
"The data submitted by [Sandoz] show that EP2006 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 suggesting that EP2006 should receive licensure for each of the 5 indications for which Neupogen is currently licensed," stated a briefing document to be used by the Oncologic Drugs Advisory Committee in a meeting Wednesday which will determine whether or not approval for the biosimilar will be given.
Sandoz also carried out a Phase III PIONEER study, announcing in December 2014 that results affirmed similarities between the company's biosimilar filgrastim and Amgen's NEUPOGEN in preventing severe neutropenia in breast cancer patients undergoing neoadjuvant myelosuppressive chemotherapy.
"The data from this important study also reinforces the results we have seen in earlier stages of development including multiple Phase I, pre-clinical and analytical studies. We look forward to making this product available to patients and healthcare providers in the United States," said Mark McCamish, M.D., Ph.D., Global Biopharmaceutical & Oncology Injectables Development head for Sandoz.
Biologics are medications made from living cells. Biosimilars, their generic version, usually cost up to 30 percent less than their biologic counterparts.