Debate regarding follow-on biologics and how the FDA will regulate them continues to rage in the halls of Washington and in the boardrooms of biologics manufacturers. But what are the legal issues surrounding follow-on biologics, and what is the likely result of FDA deliberation on the issue?
Because of the differences between regular drugs and biologics, it is impossible to guarantee that biologics from different manufacturers are identical. For this reason, the provisions of the Hatch-Waxman Act permitting an abbreviated approval process for generic drugs that can be shown to be the same as brand-name pioneers cannot currently be applied to biologic products. Brand-name biologics are thereby largely protected from the generic competition common to ordinary prescription drugs.
Because these follow-ons are not identical to the original biologic products, the FDA currently approves and licenses these products only after submission of a complete new drug application (NDA) or a biologic license application (BLA).
Proponents of the application of the abbreviated generic drug approval process to biologic products assert, however, that since these products resemble each other in much the same way that brand and generic drugs do, it is possible that these drugs could be approved without the full complement of safety and efficacy trials required for the submission of a full NDA or BLA.
To do so, however, would require a change in the way sameness or bioequivalence is currently determined under the generic approval provisions of the Hatch-Waxman Act. Such a shift would have serious repercussions on the delicate legal balance struck between the interests of innovators and the makers of generic drugs by the current policy. Thus, the FDA is attempting to play it as safely as is possible by taking a wait-and-see approach to the whole affair.
The Generic Pharmaceutical Association (GPhA) has, expectedly, made the availability of generic biologics a top priority, while the Biotechnology Industry Organization (BIO) has committed to trying to avoid their appearance. In 2003, BIO filed a citizen petition urging the FDA to act to prevent generic competition for biologics.