FDA Panel Endorses Biosimilar of Filgrastim (Neupogen)

The endorsement of EP2006 will likely pave the way for more biosimilars

A US Food and Drug Administration (FDA) advisory panel unanimously endorsed EP2006, a biosimilar of filgrastim (Neupogen), a biologic used to treat neutropenia caused by chemotherapy treatment.

The FDA is still establishing a regulatory path for these generic biologic compounds once the patent or exclusive rights of a proprietary biologic has expired. Because a biologic is a complex molecule-or even a cell or tissue-and is isolated from cells or organisms, no exact copy exists. Rather, biosimilars are close to, but never identical to, the original biologic.

The 14 to 0 vote by the FDA’s independent Oncologic Drugs Advisory Committee (ODAC) recommended approval of EP2006 for all five of filgrastim’s indications. The ODAC vote of confidence now opens the door for EP2006 to be the first biosimilar approved in the United States, and if approved, will be the first approval under the Biologics Price Competition and Innovation Act of 2009. While the FDA is not obligated to follow the advice of the ODAC, historically the agency has done so. The final FDA decision on EP2006 is expected in the first half of the year.

Filgrastim was approved by the FDA in 1991. The drug boosts white blood cell counts after treatment with chemotherapy and other therapies that lead to neutropenia. EP2006, a recombinant granulocyte colony-stimulating factor, would be manufactured by Sandoz, the generic branch of Novartis. EP2006 is already marketed outside the United States under the brand name Zarzio.

In its application to the FDA, Sandoz submitted five pharmacodynamic/pharmacokinetic studies, as well as five nonclinical studies and two clinical studies. The key study used in the ODAC’s consideration compared the efficacy and safety of EP2006 to Neupogen in more than 200 breast cancer patients who received chemotherapy.

“We are pleased with the ODAC’s recommendation to approve our biosimilar filgrastim and we look forward to continuing to work with FDA as it completes its review of our filing,” said Mark McCamish, MD, PhD, head of global biopharmaceutical & oncology injectables development at Sandoz, in a statement. “We are proud to lead the way in biosimilars globally and believe this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the United States.”