Amid growing rancor over the cost of insulin, two of the largest manufacturers are objecting to a Food and Drug Administration proposal designed to make it easier for other companies to develop lower-cost alternatives and, presumably, get these products to patients sooner. And their protests may open up the companies to still more criticism over their pricing.
At issue is a draft guidance the agency released last November to eliminate the need for immunogenicity studies for biosimilar versions of insulin. Such studies are used to determine whether an immune response occurs in the body, but there has been a growing belief they are unnecessary. The European Medicines Agency, for instance, dispensed with such studies for biosimilar insulin in 2015.
The rationale is that other clinical studies can provide necessary data for regulatory approval, and the FDA appears prepared to pursue the same approach, especially because the agency is under pressure to approve more medicines more rapidly. By doing so, the FDA can not only speed access, but may also, depending upon the medicine, lower consumer costs. And insulin is a prime example.
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