Harry L. Gewanter, MD, FAAP, FACR
Since becoming involved with ASBM on the Medical Advisory Board and, more recently, as Chairman, I’ve learned a great deal about biosimilars. Being a pediatrician, I have found that analogies are an extraordinarily helpful means to explain complex issues. This video has proven to be an invaluable teaching tool when discussing the benefits and challenges of these medications:
They are not the same. They may be close, but they are not the same. Cookie Monster has hit the nail on the head.
Biosimilars may be highly similar to their reference products, but they are not the same. This is in contrast to generic versions of chemical medications which are identical. Being a reverse-engineered molecule designed to mimic the therapeutic properties of the originator, they may be close, but they are still not the same. While we hope and expect that these new molecules will behave in the same way as the originator molecule, there may be unexpected differences, such as unwanted immune responses.
The reality that biosimilars are close, but not the same as the originator molecules is at the core of the challenges faced by regulators, physicians, pharmacists and patients. Here are but a few of the various issues that must be reconciled if we are to reap the full potential benefits of these medications:
Approval: Biosimilars need to demonstrate that they are not only similar analytically, but that they also function similarly to their reference product. How much clinical data is needed and in how many conditions are sufficient to demonstrate this high similarity remains a subject of debate.
Naming: All biologic medications (both originators and biosimilars) must be clearly distinguished from one another in order to accurately track any benefits or problems to the correct product. The global use of these miracle biologic medications calls for a worldwide agreement on their names. Both the FDA and WHO have made distinct naming a priority, but have yet to announce an “official” system.
Labeling: Transparent, informative labeling assists physicians and patients to make more informed treatment decisions when choosing between similar products. Knowing if a product is the originator or a biosimilar or for what conditions each product has clinical data versus an extrapolated approval are two examples of important information that should be on a label. Labeling regulations vary from country to country, with Canada’s policies currently requiring the greatest degree of transparency.
Substitution: Physicians and patients need to know which product – the originator or the biosimilar – was dispensed by the pharmacy in order to accurately assess the medication’s effects. While no products are currently interchangeable in the United States, the potential for non-medical substitution exists.
Notification: A majority, but not all U.S. states have enacted laws requiring communication between pharmacists and prescribers if a biosimilar is dispensed when not specifically prescribed. How this communication is to be performed and within what time frame varies from state to state.
Put simply, as any preschooler – or muppet – knows, differences matter.
Physicians, pharmacists and patients are appropriately leery of using medications for which they may not have sufficient data or knowledge of the potential variations. To fully realize the potential benefits of biosimilars – such as improved access, additional treatment choices and lower costs – policies at all levels needs to reflect that reality.