Suzette Kox, MPharm: The FDA's Guidance on Biosimilar Naming

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The updated guidance is inconsistent and it will create confusion and therefore create a safety problem. I think it’s still a possibility or hope that FDA will eventually park completely this guidance document and not apply suffixes anymore, and why we think that is because they have to take into account a number of realities. And what are those realitizes? Well, first is that FDA’s the only jurisdiction in the world which has used or applies suffixes—meaningless, unmemorable suffixes—to biosimilars and new biologics. And we believe that, because pharmacovigilance is a global activity and not only a national activity, that FDA should align with the highly regulated markets around the world, so that’s one important point of reality.

The second one, and it’s a very interesting one, is the fact that, I think it's in publication or an article of 2013, it was mentioned that we had 77 biologics on the US market which shared 23 nonpropritary names. In other words, because FDA does not apply the suffix to those products, it confirms that they don't consider that there is a safety issue or pharmacovigilance issue with biologics sharing the same nonproprietary name. And we share that with the FDA.

The other very important point is what happens today with the [adverse drug reaction, ADR] reports. When you go on the dashboard of the FDA website where they list the adverse events, somebody made the calculation, and looked every single biosimilar report, and found out that all ADRs which were linked to biosimilars have been identified to 99.1% with the brand name, so pharmacovigilance is assured. So, I think that's a very compelling point, and then maybe another important point is that I think FDA is working on a pilot project for track-and-trace, which will identify the products down to the batch number, and that’s the ultimate goal—that we identify down to the batch number—and a suffix can never do that.

From a personal perspective, because for IGBA, we have not yet finalized our comments to the FDA naming guidance, and we will do that, I think if FDA does not stick to what they have proposed now, I think they must apply the suffix also to all reference products for which biosimilars are approved. I even go further, and as I said, this is my personal opinion right now, and we’ll see if that will end up in our comment position, is that even for biologics for which which do not have a suffix now, but which undergo a manufacturing change and for which companies need to provide data to prove that safety and efficacy is not altered, that these products also need to retroactively have a suffix.