WHO biosimilars naming proposal divides industries
What’s in a name? A lot, apparently, if the name applies to a biosimilar medicine.
Responding to requests from some countries’ regulatory agencies, the World Health Organization is mulling a proposal for a global identification system for biosimilar drugs that it says will help distinguish biosimilar and original biotech products, and avoid potential confusion among prescribing physicians and healthcare agencies. But the proposal is spawning debate among pioneer and generic drug companies worldwide, and opposing reactions from industry trade groups representing both sides of the debate.
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Specifically, the WHO’s new naming plan has raised concerns among companies that produce biosimilar medicines that their products could be elbowed out of the biotech market through neglect if they carry a different name than that of the original bio-engineered drug they’re designed to mimic. Industry groups like the Generic Pharmaceutical Association fear that creating distinct, separate names for biotech products and their biosimilar counterparts would confuse prescribing doctors and pharmacists, thus discouraging substitution of cheaper me-too biologic medicines and giving an unfair market advantage to branded biotech firms.
The issue revolves around the continued use of the same International Non-Proprietary Name for original, brand name biologics and their biosimilar counterparts. The WHO, which oversees that identification system, is proposing a nomenclature system that maintains the current practice by many developed countries of using the same INN to identify both the pioneer and follow-on biologic drug. But the global health group also is proposing the adoption of a secondary, voluntary identification code, dubbed a biological qualifier, to be attached to each drug to complement the INN identification system and “avoid proliferation of separate and distinct schemes developed by individual regulatory authorities.”
“This voluntary scheme is intended to provide a unique identification code (biological qualifier), distinct from the INN, for all biological substances that are assigned INNs,” the WHO noted in a statement. “The code will consist of four letters ... assigned at random.”
Reaction was mixed, and generally broke along the divide between the pioneer biotech industry and biosimilars manufacturers and interest groups. The Biotechnology Industry Organization, representing branded biotech makers, endorsed the WHO proposal for the BQ identifier, “under which nonproprietary names of biological products that are similar to each other in structure and function are distinguishable,” noting that “distinguishable nonproprietary names enhance patient safety.”
The generic and biosimilars industries were less than enthusiastic, however. While supportive of the use of the INN for both biotech and biosimilar medications, they view the proposal for a second BQ marker as simply a tool that could be wielded by the biotech industry to head off competition from follow-on biologics.
“A biosimilar that is designed to be chemically and pharmacologically identical to the reference product should not have a different INN,” GPhA asserted. “Unique INNs ... would divorce the biosimilar from its shared regulatory history with the reference originator product on which its approval is fundamentally based.”
GPhA concluded that a separate naming system would confuse prescribers, “thwart competition” and “make the collection of post-approval data and its analysis for adverse events ... much more difficult.”