Terry MahnFish & RichardsonTerry Mahn of Fish & Richardson discusses the issues still to be resolved in the Food and Drug Administration’s proposed naming system for biosimilarsThe FDA has proposed a three-letter suffix naming system for biosimilars in a bid to maintain pharmacovigilance. Is it likely that the naming system will be introduced in the US within the next six months?
Not likely. The US Food and Drug Administration (FDA) never acts on anything until it is forced to—and this is especially the case when a politically controversial issue is involved.
Does the naming proposal present trademark issues for brands whose marks could be diluted under the proposed suffix?
The intellectual property issue gives owners leverage against competition by undermining biosimilar substitution—it is as simple as that.
In the generic world, doctors do not worry much about risk of substitution because the FDA has already determined bioequivalence via its Orange Book Therapeutic Equivalency (TE) rating system. If a TE rating system were not in place, doctors would be at risk every time they prescribed a generic in place of the brand. This would require doctors to know all about each approved generic before prescribing it and that would mean a lot of homework for doctors, and potentially more risk. Doctors do not need or want more risk.
In the biosimilar world, however, no TE rating system is being proposed, at least not yet. But a common naming system would tend to function as a possible surrogate. That is to say, if doctors could rely on a common naming system for biosimilars—one that is overseen and administered by the FDA—their risk of substitution is reduced. They would not have to read and understand every biosimilar label to manage their risk because the FDA would have done it for them via common naming.
This is what the brands want to avoid and they are hoping their IP rights in their product names will get them there.
A TE rating system similar to that which exists for small molecule drugs would be a simpler solution for everyone.
What exactly does the TE naming system stipulate?
The TE rating system in the US tells doctors and pharmacists whether drugs are substitutable for one another. For small molecule (non-biologic) drugs, an A-rated generic is fully substitutable for the brand for all indications on the brand label. The FDA does not rate substitutability on an indication-by-indication basis for small molecule drugs because they can be readily synthesised. Generic manufacturers are only required to test for bioequivalence for one indication and all others are automatically included.
Under the biosimilar system going into effect in the US, TE (and thus, substitutability) has not yet been addressed, but it is pretty clear that it will need to be implemented on an indication-by-indication basis because unlike small molecule drugs, biologics cannot be so easily copied. As long as the FDA rates biosimilars as substitutable (or not) on an indication-by-indication basis, doctors and pharmacists will need to know specifically which biosimilars can or cannot be substituted for the brand for the indication being treated.
The FDA said the effort was concerned with pharmacovigilance. How much of a problem would this be?
Pharmacovigilance would not be a problem if the ‘system’ could ensure that drug substitutions are carefully tracked and reported. The FDA requirements for pharmacovigilance fall short at present.
While common naming might help in this regard, there are other means of ensuring pharmacovigilance, such as the private sector proviso of tracking solutions. But they are expensive and no-one wants to pay for them.
What would force the hand of the FDA, to ensure pharmacovigilance?
Right now, third parties track all drug prescription and diagnostic data for every drug using anonymous patient IDs. Drug manufactures pay for this information for business purposes. So tracking is not really a problem, should it be required.
Is naming just one of the many issues surrounding biosimilars?
Naming is one of several issues. Reimbursement authorities can drive this debate if they care to, by forcing the industry (or the FDA) to create the databases needed to track biosimilar/biologic drug use.
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