Opinion: Op-Eds

FDA must decide if a biosimilar rose by any other name is still a rose

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Health,Op-Eds,FDA,Pharmaceutical Industry

"A good name is better than precious ointment." – Ecclesiastes 7:1

Federal approval of biosimilars promises to be a very good thing, but the devil is in the details. Unfortunately, we’re seeing a disturbing trend relating to one of those key details: naming nomenclature.

Biosimilars are biological drugs that are similar, but not identical, to the original FDA-approved medicines.

Advocates for nonproprietary names across innovator reference product biologics and the biosimilars associated with them dangerously miss the mark on the pivotal issues relating to naming.

Obviously much education remains to be done on this issue in the time between now and when FDA issues final draft guidance on naming.

Because where FDA winds up on this issue — nonproprietary names, nonproprietary names and identifier codes, unique names or somewhere in between — will significantly impact patients, providers, manufacturers, pharmacists, safety experts and others. We all need to side firmly with what's best for patients.

If you’re for patient safety, you can’t be against distinguishable naming. The World Health Organization established the International Nonproprietary Names system in 1953 before biologics were a figment of anyone’s imagination.

Through the INN system, innovators and generics that share the same active ingredient also share the same generic name, also called the INN.

It’s worked pretty well for chemical compounds, but, as has been acknowledged by WHO and regulatory bodies of every developed nation, biologics are not chemical compounds — they’re infinitely more complicated.

We need to learn from the market-based experiences of nonproprietary names in the European Union and Thailand, and distinguishable names in places like Japan and Australia.

We can also take valuable lessons from how approaches specific to naming of biologics lend themselves to more effective safety monitoring, pharmacovigilance, data collection, clarity and transparency.

Although the U.S. National Drug Code system will continue to serve a purpose for both small and large molecules, we can’t count on it to be the be-all-end-all solution for safety monitoring for biologics.

Not even close. Payers don’t universally use NDC codes — they are rarely present in patient records and they are often inaccurately entered when they are.

Distinguishable names provide a necessary safeguard to maximize safety and credibility. It’s really that simple.

The Federal Trade Commission is holding a hearing on the topic of biosimilar naming Dec. 10. They have stacked the deck (with exceptions) and no one is expecting anything other than the same cost-over-patient-care drivel.

I’ll be there all the same, trying (from the audience) to interject occasional bouts of patient-centric sanity.

When it comes to biosimilars, we need to be extremely thoughtful about how we set policy relating to these promising medicines and strike a balance that promotes health and safety, rather than forcing a binary response that is driven by profits rather than patients.

Here’s a nonbiosimilar quote (with apologies to Mr. Shakespeare):

"He that filches from me my good name robs me, enriches him — and makes patients poor, indeed."

Peter J. Pitts is a former associate commissioner of the Food and Drug Administration, and president of the Center for Medicine in the Public Interest. (http://www.washingtonpolicy.org/publications/brief/biosimilars-precarious-struggle-between-cost-driven-health-care-policy-and-patien)
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