Regulatory INN security? Sandoz disputes proposed biosimilar naming guidance
Last August, the US Food and Drug Administration (FDA) issued draft guidance calling for a random four-letter suffix to be added to the international nonproprietary names (INN) of all biological products to distinguish a biosimilar from its reference product.
The thinking behind this was due to “post-market surveillance,” Tomas Philipson, an economist and professor of public policy at the University of Chicago, told delegates at BIO in San Francisco earlier this month.
He said that regulators and some drugmakers believe a differentiator in the naming of such products will ultimately drive safety by adding a layer of manufacturing accountability to a marketed product.
“Firms have much less incentive to essentially provide good products because they can’t be traced back to them. Once they can be traced back to the firm, there is a much larger incentive to actually ensure safer products on the market.”
But at a media day hosted by Novartis subsidiary Sandoz in Austria last week, global head biopharmaceutical development Mark McCamish disputed such belief, and described the naming debate as “almost a little comical” with “a lot of time being spent on it when essentially the product is the same.”
Sandoz, which is investing heavily in biosimilars, believes the naming for the INN should be the same for reference products and their copycats as it is in Europe. However, he said, “the FDA is more conservative and they are looking at this from a risk-based perspective.”
The issue, he said, surrounds the FDA looking at biosimilars from a track-and-trace perspective, but if an adverse event occurs a patient will use the brand name – not the INN – to report the problem.
“We find that 98% of the time when a spontaneous adverse event is reported, it’s reported on the brand name. We rarely get the INN on the report unless we get a report from a regulatory authority and only then do they use the INN.”
Last minute negotiations
Just days after the guidance was published, Sandoz launched the first biosimilar in the US: Zarxio with the official INN filgrastim-sndz.
“We were negotiating with [the FDA] over the weekend right before it was approved, and having phonecalls because they initially gave us random four letters that didn’t make sense, like they have done with [recently approved Remicade biosimilar] infliximab-dyyb.”
Since the initial guidance, the FDA has put out a policy paper suggesting firms submit up to 10 suffixes for each new biologic or biosimilar.
When asked about this update, McCamish said: “The draft guidance took a lot of effort in trying to influence but our primary view is that no four-letter thing is needed for the INN but we haven’t been able to win that battle.
“I’m not satisfied with this or the guidance. I’d like to have it my way, but again my goal is to get things to patients so if it’s out there we will certainly comply.”