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Novartis weighs in on biosimilar naming debate

Files petition urging FDA to keep system where biosimilars share a name with the original drug

Novartis building 

Novartis has filed a petition with US authorities urging them to retain the current system to name biosimilar medicines.

As it stands, the Food and Drug Administration (FDA) requires that biosimilar medicines - a copy of a branded drug derived from living cells – share the same non-propriety name as the medicine it is based on.

However, this process has been challenged in recent months by groups, such as the Alliance for Safe Biologic Medicines (ASBM), who argue that biosimilar medicines should have their own distinct scientific name separate to the branded drug to avoid potential safety problems.

The ASBM, whose members include biologic drug developers Amgen and Genentech, are lobbying the FDA to include such measures in its biosimilar pathway, which was introduced last year to provide companies with guidance on the development of biosimilar products.

The views of the ASBM have been challenged by the likes of the Generic Pharmaceutical Association (GPhA) who want to keep the current system of biosimilar naming, claiming there is no clinically meaningful difference between a branded biologic and its biosimilar.

Now Novartis, which has a 50 per cent share of all biosimilars approved in the US, Canada, Europe, Japan and Australia through its generic medicine arm Sandoz, has given its support to the GPhA's plea to maintain current practices.

“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 Dr Mark McCamish, head of global development biopharmaceuticals and oncology injectables at Sandoz.

Novartis warned that a decision to make biosimilars carry an alternative name would create confusion and impeded their ability to compete in the marketplace.

The petition states that “assigning different international non-proprietary (IPP) names to biosimilars would introduce unnecessary confusion into the healthcare system and could unintentionally communicate increased caution, unfounded risk, or other regulatory reservations that are purely hypothetical.”

Novartis also addressed concerns that using the same IPP is unsafe, considering the FDA's need to track adverse events.

“[T]here is already a robust drug safety system in place – to report adverse events – for tracking and tracing,” said Novartis. “The current system identifies each biologic by brand names, National Drug Code numbers and manufacturer.”

Article by
Thomas Meek

1st November 2013

From: Sales, Regulatory



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