As biosims win nods in Europe and India, debate over naming rights heats up

From www.fiercepharma.com

Drugmakers, biotechs and their generic rivals are squabbling over the names that will be assigned to biosimilars, in a battle for a marketing edge.

At issue is whether biosimilars should have the same International Proprietary Name, or INN, as brand name biologics. Brand-name drugmakers and biotechs want biosimilars to have unique, non-proprietary, or generic names to distinguish the medicines from the original biologics. As they see it, distinct names would lessen confusion in the marketplace and help to ensure patient safety.

"They should not all share the same name," says Geoff Eich, who heads global biosimilar regulatory policy at Amgen. "I want to know which product was given the patient so I can work with the physician to understand what may have gone awry. We need distinguishable names because that's what tells us who to contact."

But generic drug makers disagree and believe that creating a new standard for biosimilars would, in fact, create confusion and argue that pushing for separate names is a smokescreen to blunt the inroads that biosimilars are expected to make, especially in the lucrative U.S. market.

"Having the same name is clearly important for market uptake," says Richard Davies, the chief commercial officer at Hospira. "We see the naming argument more around whether the products are different, but they're not. … Having the same name will help with market formation."

Much of the debate focuses on whether different INNs would hamper substitution needed for lowering healthcare costs. Though biosimilars won't offer the same sort of savings as garden-variety generics, they are generally expected to cost only 70% to 80% of the branded biologic. There is also heated disagreement about the extent to which distinct INNs can make it possible to spot safety issues. Brand-name drugmakers insist that different INNs will make it easier to track adverse events that might appear in patient records and post-marketing reports. A survey of 376 prescribers conducted last year by the Alliance for Safe Biologics, a group supported by biotechnology companies, found that 86% prefer to report adverse events by product name.

Of course, a great deal of money is at stake. By 2020, global biosimilar sales may reach $25 billion, according to IMS Health, which expects the U.S. to become the cornerstone of worldwide demand once the FDA begins issuing approvals. Meanwhile, eight E.U. countries--Germany, France, Italy, the U.K., Spain, Sweden, Poland and Romania--could reap cumulative savings of anywhere from $16 billion to $45 billion between 2007 and 2020, according to the IGES Institut, a Germany-based healthcare consulting firm.

The naming debate is intensifying as more biosimilars become available. In Europe, more than a dozen such medicines have been approved since 2006, including several treatments for reducing infection during chemotherapy or for combating anemia caused by chronic kidney disease. And recently, the European Medicines Agency endorsed the first biosimilar monoclonal antibody therapy.

Meanwhile, the Generic Pharmaceutical Association filed a citizen's petition with the FDA to request that all biosimilars share the same INN as original biologics. And Novartis, which owns Sandoz, also filed such a petition. At the same time, Johnson & Johnson filed a petition arguing that biosimilar names should not be identical to the underlying biologic.

"Names that are similar but not the same will appropriately reflect the legal and scientific reality that biosimilars are similar to, but not the same as their reference products or other biosimilars," says Jay Siegel, chief biotech officer and head of scientific strategy and policy at J&J.

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