To some healthcare providers and their patients, the key difference between branded products and their generic bioequivalents
is cost. If you sell a brand-name product that competes with a generic, it is your job to educate your customers otherwise.
Two tools you can use to differentiate your product and, by extension, your company based on characteristics beyond cost are
clinical data and partnership-building.
Clinical data
Physician customers and others with prescribing authority rely on clinical data to understand the indications, side effects,
precautions and other factors associated with the drugs they prescribe. The clinical research papers used to prove your product's
efficacy are your strongest sales tool. The research discussed in these papers directly studied the use of your product. It
is unlikely that the generic bioequivalents have such strong clinical research to back them up. While your product went through
a lengthy testing process, generic testing is typically limited to bioequivalence data obtained in a laboratory.
Addressing physician concerns
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The Food and Drug Administration's regulatory limits for bioequivalence do not require exact equivalence. Rather, FDA regulations
require that the 90% confidence intervals for the ratios (generic to brand) of the areas under the drug concentration-versus-time
curves (AUC ratio) and the maximum plasma drug concentrations (Cmax ratio) fall between 80% and 125%. The times to maximum plasma concentration (Tmax) should also be similar. In essence, this means that two drugs (generic and branded) with the same active ingredients are
considered bioequivalent if absorption and clearance rates fall within the 80%-to-125% window. It is thought and generally
accepted that products meeting this requirement will produce similar clinical effects. For some patients, this window is too broad. Those who are especially sensitive to particular drugs may find it unacceptable.
In addition, those needing drugs with narrow therapeutic indices, where the difference between a therapeutic versus a toxic
dose is small, may find that generics are not appropriate. If you sell a product with a narrow therapeutic index, you need
to educate your prescribing customers on this fact.
Even if your product does not have a narrow therapeutic index, differences between your product and the generic counterpart
may exist. For example, while generics must have the same active ingredients as their branded counterparts, there are no such
requirements for inactive ingredients. These include colorings, flavors, preservatives and coatings – all of which may make
a difference for some patients. While you may not be able to speak about the effects of these inactive ingredients without
clinical data to back up your statements, you can likely educate your customers that they do exist. To be sure that this is
in line with your company's promotional policies, please check with your supervisor.
Building partnerships
Another way you can differentiate your product and your company is to build strong relationships with your customers. Consider
the "relationship pyramid," which illustrates five types of customer relationships. At the bottom is where you sell a commodity
and your relationship is based on price alone. This is where most relationships between sales representatives selling generics
and their doctors reside. It is the most tactical form of selling.
