The news of FDA’s approval of Amgen’s Amjevita™, a biosimilar of adalimumab, was widely expected. It came late in the afternoon on September 23rd. Extrapolation for this agent was widely approved by the FDA, matching the indications for Abbvie’s Humira®. After all, it was the logical outcome after a 26-0 vote in July by the Arthritis Advisory Committee to recommend approval.
We may not see this product on the market for a very long time because of patent litigation, but I harbor a bit of hope that by the time of launch next year or even in 2020, the FDA will have chosen a reasonable rule for naming these biosimilars.
The nomenclature the FDA is using makes such little sense, but I I assume this to be temporary, The FDA has not yet released its final guidance on the matter. However, the horse left the barn months ago. Whatever FDA decides, they should have finalized it before approving 4 biosimilars.
So far, here are the FDA’s nonproprietary names, in order of approval:
- Zarxio® — filgrastim-sndz (Sandoz)
- Inflectra® — infliximab-dyyb (Celltrion/Pfizer)
- Erelzi™ — etanercept-szzs (Sandoz)
- And now: Amjevita™ — adalimumab-atto (Amgen)
Whereas -sndz is obvious, the rest are nonsense. I never thought I’d say this, but the strange, cobbled together syllables comprising brand names make as much sense as these suffixes. It would have been just as easy to provide somewhat reasonable designations. Not everything can be as basic as sndz, but even giving all of them alfa, beta, zeta designations could have indicated their order to the market.
At some point in time, the FDA will have to place its bets on one the red or black side of the roulette table and take heavy criticism from branded or biosimilar manufacturers, professional groups, and/or payers.
All that can be said today is that the agency seems set on a 4-character suffix, going so far as asking biosimilar manufacturers to contribute 10 preferred suffixes themselves (but even that suggestion was retracted by the agency).
Whether you approve of the suffixes or not, you probably agree that FDA ought to commit itself to one rule at this point. Whether that rule must be applied to all biologics (including reference products retroactively) is another, perhaps more perplexing, problem.