What’s In a Name? – The Battle for Naming Biosimilars
Healthcare.gov has been getting plenty of attention lately in the battle over the future of health care in the United States; however, there are other smaller, though not necessarily less important, battles being fought at the state, federal and global level as multiple parts of the Patient Protection and Affordable Care Act (PPACA) are slowly implemented.
The Biosimilar Price Competition and Innovation Act (BPCI Act), part of PPACA, is having some less headline grabbing battles as well as its implementation progresses. Skirmishes at the state level have occurred over how easily pharmacists can substitute a less expensive biosimilar for a brand-name biologic product if the FDA approves the biosimilar as “interchangeable.” Many US states are considering, or have introduced, laws related to the substitution of biosimilars at the retail pharmacy level that would require pharmacists to inform the patient’s doctor whether a biosimilar or brand-name drug was dispensed and if a substitution was made. Even though these bills would affect only a small percentage of biologic drugs that are dispensed through retail pharmacies, like Enbrel and Humira, the battle lines have been drawn, as seen recently in California. The California State Assembly voted in favor of this type of biosimilars legislation, but Governor Jerry Brown vetoed it. This was just part of a larger trend where health insurers and generic drug companies have triumphed in most states over brand-name pharmaceutical companies.
The battle is now shifting to a federal and global stage to determine whether biosimilars will have the same International Nonproprietary Names (INN) as the brand-name product. If they do not, pharmacists cannot substitute the biosimilar for the brand-name product, even if states allowed it. The World Health Organization (WHO), which oversees INN assignments, recently held a meeting where delegates called for biosimilars to be assigned the same INN as their brand-name reference product. Dr Sumant Ramachandra, Senior Vice President and Chief Scientific Officer, Hospira, pointed out that “Europe has approved biosimilars with the same nonproprietary names as their reference biologics for more than six years in a system that has proved effective.” In fact, European Union legislation requires biologics to be identified through both brand name and batch number, and not to rely solely on a unique INN differentiator. To further bolster the biosimilar naming cause, a bipartisan group of US senators sent a letter to FDA expressing their concerns on the issue of naming of biosimilars.
So, why does all this matter? With billions of dollars at stake, slowing down biosimilar use by making it more cumbersome for pharmacists to substitute less expensive versions of a biologic or by advocating for different INNs, which may call into question the safety and efficacy of the biosimilar, can extend the enormous revenues from these products for a few more years. However, Markets and Markets, a Dallas-based research company, forecasts the biosimilar market value to be $1.954 billion by 2018. Europe has about 40% of the market, while Asia-Pacific commands 29% and is considered the fastest-growing, until the U.S. market takes shape. As the US senators stated, “if biosimilars are unable to share the same active ingredient name as the brand originator product, …the intent behind the BPCIA would be undermined as would the safety and accessibility of affordable biosimilars.” In this case, we side with WHO and the senators, and agree that there is much to a name. Sorry, Shakespeare.
Blog article by: Patti Seymour