Alliance for Safe Biologics issues its response to FDA biosimilars-naming guidance


Expects World Health Organisation to follow FDA's lead

The Alliance for Safe Biologic Medicines (Arlington, VA), a business group of biotechs organized primarily to lobby for differentiated names of biotech products, supports FDA’s just-announced proposed guidance, a key feature of which is adding a four-letter suffix to the nonproprietary (aka INN) name of the compound. But it would prefer a “meaningful, intuitive suffix applied consistently to all products by a single manufacturer.” FDA has suggested a suffix “devoid of meaning;” however, in an earlier, preliminary action, it had designated Sandoz’ Zarxio (filgrastim; the biosimilar of Amgen’s Neuprogen) as “filgrastim-sndz,” which ASBM characterizes as “not only memorable and logical, [but also] promotes manufacturer accountability.”

The recommendation of the suffix, whether meaningful or not, is fraught with numerous technical and business factors—the primary of which is that originator biotech companies will be able to retain a branded position in the market, the better to keep hold of its market share and possibly to command a price premium. Originator biotechs have long argued that biosimilars, because they are molecularly distinct from the originator (due to differing manufacturing practices) will have “unexpected effects or adverse events,” and health systems need to be able to track this. On the flip side, it's also conceivable that a new biosimilar will be an improvement on the orignator product--a "biobetter"--and that could be important to prescribers and patients.

Michael Riley, executive director of ASBM, tells Pharmaceutical Commerce that it and others have been advocating for a similar naming convention at the World Health Organisation, which is currently evaluating what it calls the “Biological Qualifier.” A next meeting of WHO will be held in October. Even so, the EU and other jurisdictions have decided against distinctive naming conventions, and the Biosimilars Forum (a group of biosimilar manufacturers organized under the Generic Pharmaceutical Assn.) argue that the experience to date in Europe shows no need for the distinction.

ASBM continues to be busy lobbying state legislatures and pharmacy boards to apply some type differentiation to biosimilars; Riley says that upwards of 15 states have followed through, although California--a key biotech base--had its legislation vetoed by Gov. Jerry Brown last fall. Riley says that a new bill is working its way through the legislature.

FDA’s proposed guidance is subject for commentary for the next 60 days; a final guidance normally follows afterward.

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