FDA
13th January 2015

FDA Panel Unanimously Supports Approval of Neupogen Biosimilar

Last Wednesday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously 14-0 in favor of approving EP2006 (proposed trade name, Zarxio) for all 5 indications currently approved for its reference drug, Neupogen (Amgen Inc.).

FDA Panel Unanimously Supports Approval of Neupogen Biosimilar

Last Wednesday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously 14-0 in favor of approving EP2006 (proposed trade name, Zarxio) for all 5 indications currently approved for its reference drug, Neupogen (Amgen Inc.). ODAC agreed with FDA reviewers, stating that there were no “clinically meaningful differences” between Zarxio and its reference drug.

In an effort to increase patient access to healthcare and life-saving drugs, The Patient Protection and Affordable Care Act (Affordable Care Act or ACA), was signed into law by President Obama on March 23, 2010.  The ACA amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product.  This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act).  Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product.  gic drugs are made from living cells and have been proven to be highly effective in treating cancers and immunological diseases. To date, hefty price tags due to lack of competition, have  limited their use.With this historic vote, Zarxio becomes the first biosimilar drug to be reviewed in the United States under the biosimilar pathway and recommended for approval. Biosimilars are essentially copies of biologic drugs, and are expected to cost 20-30 percent less than their reference biologic. Biolo

Sandoz Inc., the creators of Zarxio, is a Novartis company, and currently sells the product under the brand name, Zarzio, in over 60 countries outside the United States.

The FDA is not bound to follow its panel’s recommendation, but normally does so.

Innovative Science Solutions is proud to have been Sandoz’ AdComm support vendor and to be a part of this ground-breaking advisory committee review.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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