A Major Loss for Consumers: FDA Proposed Rule on Biosimilar Naming Threatens Savings and Offers No Gain in Safety

shutterstock_46772755 This morning’s proposed rule on biosimilar naming marks a major win for PhRMA and BIO and a loss for consumers, not to mention a reversal of FDA policy.  At a time when more than 70% of Americans believe drug companies put profits before people, the FDA’s proposed rule helps them continue to do just that.

While it is arguably true that biologic drugs are somewhat more complicated than traditional chemical compounds and certainly true that very few policy makers and consumers truly understand the science behind these often groundbreaking drugs, this in no way should mandate that biosimilars (essentially the generic version of these drugs) should have a different medical name (formally known as a “nonproprietary name”) than the original product.

Think of it this way: If your doctor were to tell you to take 200mg over-the-counter Ibuprofen as an anti-inflammatory, you could go to the store and choose between Advil and the store-brand Ibuprofen, sitting side-by-side on the shelf.  You would have your own opinion about whether to get the branded version of the medication or the store brand but you would know that the ingredients were the same because each bottle would be labelled “200mg Ibuprofen.”  Under the scheme proposed by the FDA, your doctor would look up the name of the biologic and not necessarily see the biosimilar because they wouldn’t both have the same medicine name.

Why Does This Hurt Consumers?

A biosimilars pathway was created as part of the Affordable Care Act to make important medications more affordable, and thus more accessible, to those who need them.  By imposing a unique name on biosimilars, the FDA largely eliminates the potential savings of biosimilars.  Generics are able to be sold at a lower price than the brand version of a medication in large part because it is not necessary for them to advertise (or in pharmaceutical speak “detail”) the product, as the product has the same medicine name and sits side-by-side on the shelf (or next in line in a computer drop-down menu).  Under the proposed scheme, biosimilars companies will have to spend tremendous resources to inform providers that the product exists and should be considered as an alternative.  This added cost will be passed along to consumers, losing them valuable savings.

In countries like the United Kingdom, Japan and Australia, which already have biosimilars available on the market without similar restrictions, consumers have experienced significant savings and there have been no reported safety concerns.  There are even anecdotes about doctors using medications sooner, even prophylactically, with great outcomes for patients, but only because they can afford to take this approach.

Why Does It Not Improve Safety?

The reality of the biosimilars pathway created by the ACA is that it is, and has been implemented to be, extraordinarily cautious.  Every safety concern has been addressed and the FDA is imposing rigorous review on all market entrants.  Unknown to many, the biosimilar product actually is required to be manufactured in a way that is more rigorous than the requirements placed on the original product.  So, quite literally, the biosimilar is in some ways safer than the original.  This is not to suggest that your doctor should not carefully consider whether she believes the original product might be better suited to a particular patient, but the doctor should have readily available the knowledge that a biosimilars product is available.

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