Image: Novartis AG
1 November 2013Americas

Novartis petitions FDA on biosimilar naming convention

Novartis has urged the US Food and Drug Administration (FDA) to allow biosimilars to bear the same international nonproprietary names (INNs) as their reference products.

In its petition filed with the FDA on October 28, the Swiss pharmaceutical company said that assigning different INNs to biosimilars would create “unnecessary confusion” in the healthcare system, and undermine the FDA’s established practice of reviewing and approving manufacturing changes of originator biologics without requiring new INNs.

“A biosimilar, by definition of its approval, has successfully met FDA’s demanding standard of high similarity to a reference product,” Novartis said in the petition.

It also argued that unique INNs for biosimilars could lead to medication errors, which could jeopardise patient safety.

Biosimilars are treatments made to mimic biological products, which are made from materials sourced from living organisms. Many companies have argued that biological products are too complex to be copied by generic companies.

However, since the introduction of the Patient Protection and Affordable Healthcare Act, or Obamacare, in 2010, the FDA has been working on establishing standards for licensure to ensure biosimilars’ safety and effectiveness. No biosimilars have yet been approved by the FDA.

“Practitioners around the world have relied on the present naming convention for over 50 years, and the introduction of biosimilars does not warrant a change in this policy,” said Mark McCamish, head of global development biopharmaceuticals and oncology injectables at Sandoz, Novartis’ generic pharmaceutical division.

“We believe that a modified INN would thwart patient access and prevent the US from receiving the full cost-saving benefits of biosimilars enjoyed in Europe and other highly-regulated markets.”

A spokesperson for the FDA told LSIPR: "The FDA is currently considering the appropriate naming convention for biosimilar products and interchangeable products licensed under the pathway established by the BPCI Act enacted as part of the Affordable Care Act.

"The FDA is carefully reviewing and considering the comments submitted to the biosimilar draft guidance and public hearing dockets. We will take into consideration all comments as we move forward in finalising the draft guidance documents and in developing future policies regarding biosimilar and interchangeable products, including naming."

The World Health Organization has administered the INN system since 1953.

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