Disappointing News on INNs from the FDA | Citizens Against Government Waste
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Disappointing News on INNs from the FDA

The WasteWatcher is the staff blog of Citizens Against Government Waste (CAGW) and the Council for Citizens Against Government Waste (CCAGW). For questions, contact blog@cagw.org.

You may recall I have written about the World Health Organization’s (WHO) naming system for drugs, called the International Non-Proprietary Name or INN, in a January 15, 2015 Swine Line blog and in a Citizen’s Against Government Waste August (CAGW) August 2014 WasteWatcher.  The INN was created by the WHO more than 60 years ago and its purpose was to provide an international identification system of pharmaceutical substances. The INN is often called the generic name of a particular drug because the drug can be sold under different brand names.  For example, atorvastatin is sold as Lipitor in the United States but as Zarator in Denmark and New Zealand.  Having an INN, or the generic name, allows doctors and scientists across the world to communicate about the same drug even though the brand name may be different.

This naming policy worked fine for chemically-based drugs but became controversial with the development of biosimilars, the “generic” version of biologic drugs, which are made of natural substances obtained from humans, animals, or microorganisms.  While Europeans have had access to biosimilars since 2006, the Food and Drug Administration (FDA) had no abbreviated licensure pathway to approve biosimilars until passage of the Biologics Price Competition and Innovation Act in 2010.  Since then, the FDA has been writing regulations and guidelines informing drug manufacturers what would be required of them to get a biosimilar approved in the United States.

In January 2015, the FDA held its first advisory committee meeting on whether to approve a biosimilar alternative to Amgen’s Neupogen.  The drug is used to boost white cell counts for patients undergoing chemotherapy for cancer. In this particular case the INN, or generic name, for Neupogen is filgrastim.  The committee recommended approval of the biosimilar manufactured by Sandoz.  The biosimilar will be marketed as Zarxio in the U.S.  But an important question needed to be addressed: what should Zarxio's "generic" name be? Should the generic name be filgrastim or something else?  Amgen, and other brand-name pharmaceutical companies, wanted a completely different generic name for all biosimilars while generic companies called for the same INN, just as had been occurring for chemically-based drugs for more than half a century. Whatever the decision, it would affect all future biosimilars that came to the market in the United States.

In the European Union, biosimilars have been sharing the same INN as the branded drug for years.  Sharing the same INN allows doctors and pharmacists to more easily substitute the less expensive biosimilar for the brand-name biologic drug, just as they do now with chemically-based drugs.

CAGW agreed with the generic drug industry that creating separate INNs was simply an effort to stifle access to these new and competitive products.  Having two different generic names for corresponding biologics and biosimilars would be confusing and send a false signal they were vastly different from one another even though they would have no clinically meaningful difference.

Last week, the FDA made its decision and it was disappointing.  The agency has proposed to add separate and a random 4-letter suffixes to the INN for both the brand-name biologic and the corresponding biosimilar.  In reality, it was not surprising because WHO had proposed adopting such a naming system a year ago.

Therefore, Neupogen’s generic name will go from just filgrastim to filgrastim-jcwp and Sandoz’s biosimilar will have the generic name of filgrastim-bflm.  However, the FDA has also asked for feedback to see if the four letter suffixes should have some meaning, such as including part of the manufacturer’s name.  Examples of such a scenario would be filgrastim-sndz for Sandoz’s biosimilar and filgrastim-amgn for Amgen's Neupogen.

Likely the FDA sees this naming policy as a compromise due to the intense lobbying from both the brand-name and generic industry.  The generic industry fervently wanted the same INN for a biologic and its corresponding biosimilar, while the branded drug industry just as ardently preferred completely different INNs.

In any case, the FDA just announced that Sandoz can market its biosimilar Zarixo as soon as Sept. 3, 2015.  A new era has begun and soon U.S. patients will get access to cost-saving biosimilars.

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