Widespread adoption of biosimilars – biologic drugs the U.S. Food and Drug Administration (FDA) is expected to approve starting as soon as next year – will provide Americans with greater access to life-impacting drugs, along with significant cost savings.
Biosimilars are new, follow-on versions of expensive, biologic medicines that have improved the quality of life for patients suffering from some of the most widespread and difficult-to-treat illnesses, including cancer, chronic kidney disease and auto-immune disorders, such as rheumatoid arthritis and ulcerative colitis. But before the United States can fully access these drugs, the FDA must make several key policies and regulatory guidelines clearer, including the establishment of naming guidelines, which will have a significant impact on the adoption of biosimilars.
Drugs generally have two names that are important to patients and clinicians: the brand name like “Advil” or “Motrin,” and the common shared international nonproprietary name (INN) like “ibuprofen.” Similarly, up to now, most biosimilar versions of drugs have their own distinguishable brand name. Moving forward, it is expected that companies will continue to adopt their own brand names for these biosimilar drugs, as they have done in Europe and Australia and as we expect will be the case in the United States; this brand name makes a biosimilar drug distinguishable from the originator biologic drug.
Having a common, shared INN can be a simple way of communicating that biosimilar drugs are highly similar to their originator drugs at both the product level and the clinical activity level, as they have the same active ingredients. That way, health professionals know what drug they are prescribing and patients get the drugs they were prescribed. This system of having the same INN for the originator drug and the follow-on drug has worked for over three decades for the generic industry – so, why change it now?
As with the naming of generics, effective naming of biosimilars must be simple and intuitive for all key stakeholders. That is why accessibility and patient safety are best ensured when biosimilars share the same “nonproprietary” name with the originator biologic.
A drug’s INN is very important. A simple name change will have a significant impact on how biosimilars are used in the United States. If naming confusion leads to greater uncertainty among clinicians and patients, adoption rates will be lower as prescribers will stick to what they know – the higher-priced originator biologic drug; this could significantly reduce expected savings, which are projected in the United States to be up to $250 billion in the first decade.[i]
The World Health Organization (WHO), which created the INN system decades ago, recently proposed a new standard to keep the same INN for biosimilars, while applying a “non-attached” biological qualifier retroactively and prospectively to all biologic products on the market. This is a positive step in the right direction for biosimilars. Biosimilars are also biologics and should be treated the same way from a naming and label perspective to avoid confusion and increase access for patients.
Certain elements of the WHO proposed naming program regarding INNs are aligned with current practices in experienced regions, including Europe, where biosimilars have been prescribed since 2006. In particular, the portion of the proposal to keep the INN the same is in line with EU practices. At Hospira, where we have extensive experience in biosimilars in Europe and in Australia, we are supportive of keeping the INN the same and, if needed, applying a biological qualifier in regions of the world where this qualifier will enhance tracking and tracing of biologic products. Patient safety and accessibility are best ensured when a biosimilar shares the same INN with the originator biologic after which it is modeled, allowing physicians to continue prescribing by brand name. The European experience with this showcases the soundness of this approach.
I’ve personally experienced the negative impact of different INN names. When I was a practicing physician, I was on vacation in a large European country when I got a bad headache. I stopped in a local pharmacy to get the common pain reliever known as acetaminophen, but when I asked the pharmacist for the drug, he said he didn’t know what I was asking for and offered ibuprofen for my pain instead. I typically avoid taking ibuprofen because I can have a mild asthmatic reaction to it. It seemed impossible that acetaminophen would not be available in a European pharmacy, but it became clear we were not communicating. I gave up and took the ibuprofen.
Later, I discovered acetaminophen is the rare example of a drug that has a different nonproprietary name in the United States than in Europe. What we call “acetaminophen” is known as “paracetamol” in Europe and other countries. Even though I am a physician specializing in internal medicine, I was not familiar with this European version of the nonproprietary name and could not obtain the medicine that was best for me.
This example captures the crux of the problem when it comes to giving biosimilars different INNs — if clinicians and patients see a different name, they will not be able to identify it, or will assume it is a different drug. They will believe biosimilars have a different clinical effect from the originator biologics.
I am not alone in this belief. In July, 32 payers and other interested organizations wrote the FDA to note their concern about giving biosimilars a different INN than the originator biologic. Last year, leading Senators wrote FDA Commissioner Margaret Hamburg in support of the same INN name for biosimilars. I have also written on this topic previously and have presented on several occasions, on behalf of the Generic Pharmaceutical Association (GPhA), to the World Health Organization.[ii]
Some originator biotech and pharmaceutical companies and members of the medical community argue that biosimilars must have a different INN because they are slightly different from the biologics they are modeled after. Biosimilars and biologics are made from living materials, meaning slight differences between products, even between batches of the same medicines, will exist. Over time, slight changes appear in existing biologic medications — this is known as “drift” — and can occur even if a biologic is produced consistently in exactly the same way, by the same manufacturer, using the same tools. Yet the FDA does not require these “drift” products to receive different INNs, acknowledging that physical differences in biologic drugs are acceptable as long as they deliver comparable clinical results.[iii]
Another misleading argument for distinct INNs is that having different INNs will help improve tracking for potential incidents, or, in technical terms, pharmacovigilance. Yet there is no evidence to back up this argument. Hospira reviewed information gathered on two of our biosimilar drugs sold in Europe since 2008 and 2010, respectively; we found that patients and clinicians included the brand name of the biosimilar when reporting an event in 99 percent of cases for one product and 95 percent of cases for the other.ii In general, healthcare providers and others who report do not use the INN alone but include the brand name as well. This shows that biologic and biosimilar products can be adequately tracked without different INNs. That does not even take into account the other methods of tracking pharmaceutical products in the United States, like the manufacturer’s name, the National Drug Code (NDC) and batch number. In the near future, bar coding and other more complete mechanisms will be used to ensure that biologic products are properly tracked and documented.
As the WHO guidelines are voluntary, it is reasonable that in highly developed regulatory environments like Europe and the United States, local regulatory bodies will set their own requirements. Yet the international system established by the WHO has been the gold standard for more than four decades. The WHO’s biosimilars guidelines should be considered for new markets. The closer we move toward a global biologic naming system, the greater our ability to avoid confusion in the global healthcare community and to avoid unnecessary costs region to region and country to country.
U.S. policymakers and regulators should make note of Europe’s eight years of experience of safely allowing biosimilars with the same INN to be marketed and take heed of the WHO’s position on maintaining the same INN and, where needed, the presence of a biological qualifier. We, in the United States, will have the ability to impact healthcare in a very positive way starting next year with the competition that biosimilars will bring. It is up to us to chart a path that delivers the maximum value of biosimilars to patients.
Sumant Ramachandra, M.D., Ph.D., MBA is Senior Vice President and Chief Scientific Officer at Hospira, Inc.
[i] Miller, S. 2013, The $250 Billion Potential of Biosimilars. Healthcare Insights from the Express Scripts Lab, April 23, 2013 http://lab.express-scripts.com/speciality-medications/the-250-billion-potential-of-biosimilars/
[ii] Ramachandra, S., “What’s in a Name? The Importance of Biosimilar Nonproprietary Names for Healthcare Innovation.” http://www.hospira.com/Images/What’s%20In%20a%20Name%20-%20Hospira%20Policy%20Paper%20-%20Oct%202013_81-92092_1.pdf.
[iii] Christian Schneider, “Biosimilars in rheumatology: the wind of change.” Annals of Rheumatic Diseases 72 (March 2013): 315-318.\