REGULATORY REACTIONS
Biogenerics are post-patent versions of biologics, and they go by various names, called biosimilars in Europe and follow-on-biologics (FOBs) by some in the United States. By any name, though, no regulatory pathway governs this burgeoning industry in the United States. Fortunately, Europe has developed a regulatory structure, although it leaves some gaps.
The fact that even the name of such products comes down to a matter of opinion reveals some of the challenge. Many dismiss the term "biogenerics" because, unlike chemical drugs, there can be no exact copy of a biotechnology product. So there can be no "generic."
Developing satisfactory regulations, however, presents more complicated obstacles than picking a name. For example, even small differences in biotechnology products have been known to cause uncertain outcomes in efficacy and safety and can create unique hazards such as immunogenicity. In addition, there are a wide variety of biotechnology products, and taking a one-size-fits-all approach is unlikely to succeed. In some cases biologics have a relatively simple structure while others have highly complex structures, which might require a different regulatory approach.
To handle the last point, Europe created a case-by-case consideration of new applications for FOBs. That means that an effort to produce a new version of an innovator drug might require only a few studies, or it might require so many that it's almost equal to a new drug application.
The authority for deciding what rigors and standards an application will have to meet is up to the European Medicines Agency (EMEA). Some in the United States might feel that the user fees from the Prescription Drug User Fee Act (PDUFA), which make up such a large portion of the Food and Drug Administration (FDA) oversight budget, might put the agency under too much industry influence to be entrusted with that responsibility. Any such fears might be assuaged by the fact that approximately 75% of the EMEA budget also comes from user fees.
A key question in the approval of FOBs is that of interchangeability of a FOB with an innovator product. Who will make the decision to use a FOB in place of the innovator biologic compound? Will it be the payer, the prescriber, the pharmacist, or the patient? The European approach does not have provision for addressing this issue. That might result in a patchwork of approaches across Europe, where a biosimilar product and an innovator drug are used interchangeably. Without some way of tracking what was used and when it was used and on whom, the clinical outcomes may vary, and pharmacovigilance would be impossible.
Still, the European experience in creating a regulatory pathway for biosimilars/FOBs is quite young. Also, it is early for very many informed "lessons." In the United States, though, cost pressures of medications will force legislative and regulatory action on biotechnology medicines, and the resulting regulatory pathways must allow for an increasingly sophisticated and complex set of challenges as more biologics come off patent.
