By Peter Pitts
April 10, 2018 at 5:00 am ET
When it comes to health care, clarity is better than confusion. Nowhere is that philosophy more important or timely than when it comes to drug safety — the sine qua non of the Food and Drug Administration. Case in point: nomenclature for emerging biosimilar medicines.
What’s so important about a biosimilar’s name? Patient safety. According to the FDA, distinct and precise nomenclature for all biologics, innovator and biosimilar, will promote accurate prescribing and facilitate accurate attribution of adverse events.
Distinguishable naming is imperative because biosimilar therapies are similar to, but not exactly the same as, existing biologic medicines. Since no biosimilar is perfectly identical to its innovator parent, every biosimilar must be fully distinguishable to permit quick and accurate tracing of its manufacturer, should an adverse event be observed. That’s why the FDA requires makers of innovator biologics and biosimilars to have nonproprietary names that include a distinct suffix.
On a global level, an International Nonproprietary Name is used to identify the active ingredient in a drug, which in the case of a chemical/generic drug is equivalent. Biosimilars aren’t identical to their innovator parents; they are “highly similar.”
The differences, however, are crucially important since there is the potential for all biologics to elicit dangerous immune responses. For this reason, if biosimilars use identical INNs and prescribing, dispensing or adverse event records identify products only by INNs, global regulators can’t recognize precisely which product is causing a problem. Per the FDA’s thinking, the addition of a unique suffix to the nonproprietary name provides a distinguishing feature that can be used to enhance traceability in a marketplace with multiple similar options.
Precise naming will improve patient safety by reducing confusion and mishaps in prescribing — holding manufacturers accountable. Also, differential nomenclature helps enable payers to collect and compare real-world data that measure the clinical effects of biologics including biosimilars. Insights from such data, over time, will enable us to better measure a drug’s effectiveness in delivering successful health outcomes for patients.
Biosimilars offer the opportunity for lower costs through increased commercial competition. Importantly, being able to consistently identify a product will boost prescriber and patient confidence and enhance a robust marketplace of safe and effective therapeutic alternatives.
Distinguishable naming can help to build confidence in biosimilars and help with uptake, which can help Americans to realize the potential for cost-savings. While the price differential between a traditional “small molecule” brand-name drug and its generic can be upward of 85 percent, biosimilar price savings will be more modest, about 10 to 35 percent. Still, that’s a substantial cost reduction since the prices of biologic drugs are much higher.
While estimates have varied widely, a RAND Corp. analysis estimates that biosimilar drugs could reduce spending in the United States by $44 billion over the next decade. The Congressional Budget Office estimates more conservatively that biosimilar medications could generate $25 billion in savings for patients and taxpayers over 10 years. But only if physicians have faith in the system.
What’s in a name? Why is clarity so important? Safety and savings.
Differential biosimilar names also provide a third dimension of benefit — they enhance commercial competition by rewarding innovation and consistent, high-quality manufacturing standards. Getting a biosimilar through the FDA process and into the marketplace takes seven to eight years at a cost of between $100 million and $250 million. Over time, enabling traceability will reward drugmakers who commit to consistent, high-quality standards following approval. Clarity is the foundation of predictability — and regulatory predictability weighs heavily on the risk/reward seesaw.
When it comes to biosimilars, smart regulation for accurate product traceability means that success will be measured by patient outcomes. Distinguishable names provide that transparency and a necessary safeguard to maximize safety and credibility. Clarity must trump confusion.
In the immortal words of Oliver Wendell Holmes, “Speak clearly, if you speak at all.”
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and consultant for various life science companies.
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