Biosimilar Battlefronts

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  • 10/01/2013

If you’re following the multifaceted and global debate over biosimilars, Steve Usdin’s article, Biosimilar battlefronts, is a must read. Authored by BioCentury's Steve Usdin, it’s opening paragraphs set the tone,

Biosimilars developers, manufacturers of originator biologics, payers and consumer groups are battling in state capitals, at FDA headquarters, and at the World Health Organization in Geneva over the rules that will shape perceptions and prescribing practices for copycat biologics in the U.S. and around the world.

Separately, none of the conflicts will have a decisive effect on either biosimilars developers or manufacturers of the products they hope to replace. But collectively, state laws on interchangeable biosimilar substitution, national and international naming practices, and FDA's labeling policies could have powerful effects on the market penetration of biosimilars.

The article covers many issues, both foreign and domestic – and one of the most important and most contentious is the issue of the nonproprietary names assigned to biosimilar and interchangeable biologics.

Usdin writes,

Proponents of distinctive non-proprietary names, including some of the biggest biotech companies, say patient safety and possibly the viability of whole classes of biologic drugs would be threatened by a failure to adopt their recommendations.

However, European regulators say distinct non-proprietary names are unnecessary, and some biosimilars companies argue such a naming scheme would put a dark cloud over biosimilar products that would substantially reduce sales.

A WHO group will meet on Oct. 22 to debate biosimilars naming principles.

The basic disagreement: one camp is arguing for biosimilars to keep the same international non-proprietary name (INN) as the reference product; a second camp argues for distinct INNs.

Supporters of distinct INNs say the ability of regulators to track and trace biologic drugs is essential for patient safety and the commercial viability of biologics — original and biosimilar. Opponents of distinct INNs say they are intended to confuse and scare physicians, patients and payers by drawing unnecessary distinctions between original biologics and biosimilars.

According to Geoffrey Eich, executive director of R&D policy at Amgen, “It seems counterintuitive, like sticking your head in the sand, to not want to include a distinguishing feature that allows us to aggregate info when appropriate and disaggregate when appropriate.”

Amgen supports the use of the reference product’s root INN, with the addition of a unique suffix or prefix for each biosimilar. “We believe having some kind of a distinguishable feature is absolutely essential to patient welfare, for pharmacovigilance,” Amgen’s Eich told BioCentury.

A WHO working group will meet Oct. 22-24 to discuss the creation of voluntary international standards for non-proprietary names for biosimilars.

WHO isn’t likely to adopt a final naming policy at the October meeting. Whatever policy it eventually adopts will not be binding, but it is likely to be adopted by developing countries, and, if it includes a distinctive naming system, could intensify pressure on European countries to adopt new naming policies.

Without casting any aspersions, “quality” and “pharmacovigilance” in developing countries takes on an entirely different meaning than similar concepts in more developed regulatory regimes.

At a meeting in Pretoria last week Tomas Salmonson, Chair of the EMA’s Committee for Medicinal Products for Human Use (CHMP), said that the working group is “split down the middle” on the issue of naming.

Stay tuned.

We do what we must, and call it by the best names. -- Ralph Waldo Emerson


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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