And Ivan Ackerman. Always the wrong answer. Always.
According to Inside Health Policy, an American Medical Association internal council report reveals the group is leaning toward a naming scheme where biosimilars and their reference products would share the same International Nonproprietary Names (INN). The report says that unique names may suggest different active ingredients within the products and go against standard nomenclature. This stance differs from that of the innovator biologics industry and a handful of specialty physician groups, which argue that shared naming would improperly imply interchangeability.
Assigning differential naming to biosimilar products will certainly prove challenging to the various constituents of the drug compendia community — but it will be crucial for pharmacovigilance. In the real world, how can we not have separate names when there are going to be four categories of products?
Based on comparative analytical data, FDA will characterize its assessment of biosimilarity into one of four levels -- not similar, similar, highly similar or highly similar with a fingerprint-like similarity — depending on the type, nature and extent of any structural and functional differences revealed.
Additional pharmacologic studies would be required to show that the identified difference is “within an acceptable range to consider the proposed biosimilar product to be highly similar to the reference product.”
FDA said only products in the top two tiers would meet the statutory requirement for analytical similarity under the Biologics Price Competition and Innovation Act of 2009. Products in the top two tiers would then only require “targeted and selective animal and/or clinical studies to resolve residual uncertainties” to demonstrate biosimilarity. In addition, these data could be used to extrapolate clinical data for additional indications.
The argument that differential naming is bad for patient safety is pure Orwellian Newspeak — specifically “blackwhite, ” The ability to accept whatever “truth” the party puts out, no matter how absurd it may be — no matter the lack of supporting data. When it comes to biosimilar nomenclature, it’s urgent that we keep our priorities straight. And that means keeping patient safety, not interoperability challenges, at the top of the agenda. Fortunately, White Oak trumps blackwhite.
The good news is that a handful of specialty physician groups disagree with the AMA and are siding with the innovator biologics industry in urging FDA to adopt a biosimilar naming scheme under which products have distinguishable names, pushing back against arguments made by an American Medical Association council and generic drug makers for shared International Nonproprietary Names (INNs). The groups, like innovator companies, argue that distinct names are needed to track adverse events and to protect against improper pharmacy substitution.
The specialty physician groups wrote to FDA on December 18th that a shared name would imply interchangeability, referencing statements made by the agency in past about how INNs should not be used to "imply pharmacologic interchangeability of products with the same active ingredient(s)."
Signers of a the letter include: Alliance for Patient Access; American Academy of Allergy, Asthma & Immunology; American Association of Clinical Endocrinologists; American College of Rheumatology; American Gastroenterological Association; Association of Black Cardiologists; American Urological Association; Clinical Immunology Society; Coalition of State Rheumatology Organizations; physician co-conveners Biologics Prescribers Collaborative; and members of the National Physicians Biologics Working Group of the Alliance for Patient Access.
For a more complete debunking of the AMA’s position, see the recent FDLI paper, Biosimilar Nomenclature: Can we Achieve the Truth, the Whole Truth, and Nothing but the Truth?
Claude Debussy said, ‘‘Music is between the notes.’’ And the same can be said for biosimilarity and the practice of medicine. We now have many thoughtful guidance documents but, in many respects, it’s just theory. And just as the case with music theory, the words on the page are one thing—but when talented performers sit down at different pianos in disparate venues the results are both similar and unique.