US FDA approves first biosimilar, keeps quiet on naming standards

The US Food and Drug Administration (FDA) approved Sandoz’s cancer product Zarxio (filgrastim-sndz) on Friday (March 6)—the first biosimilar to be rubber stamped in the US.

However, the FDA did not clarify naming standards for biosimilars. This issue has been closely watched by both the biologic and biosimilar sectors.

Biosimilars are similar versions of biologics, medicines such as vaccines that are generally derived from living organisms.

Sandoz’s Zarxio is a biosimilar version of Amgen’s Neupogen (filgrastim), an injection that helps to reduce the risk of infection in cancer patients receiving chemotherapy. The FDA has approved Zarxio for all indications included on Neupogen’s label.

Zarxio is the first biosimilar to be approved under the new abbreviated biosimilars pathway, established under the Biologics Price Competition and Innovation Act (BPCIA), which was introduced in 2009.

The FDA described Zarxio’s name, ‘filgrastim-sndz’, as a “placeholder” non-proprietary name, though it said this should not be viewed as a decision on a comprehensive naming policy for biosimilar and other biological products.

“While the FDA has not yet issued draft guidance on how current and future biological products marketed in the US should be named, the agency intends to do so in the near future,” it said.

Ralph Neas, president and chief executive of the US-based Generic Pharmaceutical Association (GPhA), said the approval of Zarxio “heralds a new era for cancer patients and the American health system”, but lamented the lack of guidance from the FDA.

“As the FDA continues its work to implement the BPCIA, we reiterate our stance that the agency’s departure from the currently accepted international non-proprietary names (INN) system could disrupt the ability to track and dispense these medicines, risking provider confusion and patient safety.

“GPhA and more than 30 health organisations agree that it is critical to preserve the system already proven to be safe and effective worldwide,” Neas said.

In November 2013, Sandoz’s parent company Novartis petitioned the FDA to allow biosmilars to have the same INN as their reference products.

However, some branded biologics makers think that biosimilars should have different names from their reference products so that any adverse effects of the new versions can be properly ascribed to them.

Outside the US, Zarxio is known as Zarzio and is available in more than 60 countries. It was approved by the European Medicines Agency in 2009.

The FDA, before reaching its decision to approve Zarxio, verified that there was no “clinically meaningful difference” between the biosimilar and Neupogen, determining that the two would work in the same way.

Leah Christl, associate director for therapeutic biologics at the FDA, said that biosimilars are likely to create greater competition in the marketplace, creating more treatment options for patients and leading to cheaper medicines.

Carol Lynch, global head of biopharmaceuticals and oncology injectables for Sandoz, said that the FDA’s approval of Zarxio marks a “significant milestone” for the US healthcare system.

“We are honoured to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US,” she added.

Amgen did not respond to a request for comment.