Dr. Diane Lacaille
Scientific Director of Arthritis Research Canada/Arthrite recherche Canada
Dr. Neeraj Narula
Director, IBD Clinic, McMaster University & President, Canadian IBD
Research Consortium
Dr. Janet Pope
Division Head in Rheumatology, St. Joseph’s Health Centre & Professor of Medicine, Western University
Biosimilars offer patients and clinicians hope, increasing access to new innovative treatment options.
Incredible advancements in healthcare have allowed clinicians to treat disease areas that — for years — have eluded them. From arthritis to diabetes, developments in how we treat conditions are likely to have played a substantial role in increasing the global lifespan by roughly a decade over the last 50 years.
Biosimilars are one such advancement, helping the health-care industry reimagine disease treatment. Biosimilars emerged over the last two decades, resulting from the global health-care system’s growing reliance and comfortability with biologic medications. They’re changing the way we approach diseases, while at the same time offering health-care systems the ability to invest in newer, innovative options.
Breaking down biologics
Most medications found in the average Canadian’s medicine cabinet are considered synthetic drugs. In structure, these drugs are relatively simple and can be easily copied. A generic drug is a lower-cost alternative, replicating the synthetic’s exact chemical structure, hitting shelves once the patent on the original expires.
Meanwhile, biologic drugs are made by living cells, created through a biological process. This means they have a targeted effect on how cells function, honing in on the specific processes responsible for causing negative disease outcomes. Insulin — perhaps the world’s first biologic — is a familiar example, not only having played a role in changing the way diabetes is treated but helping to advance iterations of biologic treatment for the indication.
“The real advantage to a biologic medication is that they’re incredibly effective, more so than traditional medications,” says Dr. Diane Lacaille, Scientific Director for Arthritis Research Canada.
However, as they’re created with living cells, biologic drugs require a complicated development process involving state-of-the-art technology and very controlled environments. This complex process leads to inherent variability in the resulting product, so manufacturers must complete extensive trials before Health Canada approves a biologic for use — an expensive, time-consuming process.
Naturally, scientific minds wondered: what if these medications could be developed in a timely, less costly way without losing their effectiveness?
The real advantage to a biologic medication is that they’re incredibly effective, more so than traditional medications.
Dr. Diane Lacaille, Scientific Director for Arthritis Research Canada.
Enter biosimilars
Like generic drugs, biosimilars are replicas of an original biologic medication (“the originator”) created after the original manufacturer’s patent expires. Unlike a generic, a biosimilar, while a close copy, is not the exact same. Due to the complex process required to create a biologic medication, a biosimilar will show intrinsic variability to the originator. As a result, biosimilar manufacturers must prove the drugs closely replicate the originator — both at the molecular and cellular levels.
Biosimilars rely on evidence from the many randomized control trials conducted for the originator biologic. While the high manufacturing costs and processes remain the same, the company’s ability to extrapolate data from the original trials allows them to save money during the biosimilar’s research and development phase. Simply put, biosimilars are so similar to their originator, provided they’re seeking approvals for the same disease indications, there’s no need for them to go through the same rigorous trials. In other words, the originator forged the way for the biosimilar to reap the rewards. As a result, the biosimilar can be offered at a nearly 50 per cent price reduction.
“Biosimilars aren’t cheaper as in a lower quality alternative drug; they’re incredibly highly regulated and deliver the same therapeutic benefits to patients,” Dr. Lacaille says.
Saving the system
Biosimilars have been approved in Canada since 2009. In that time, they’ve revolutionized the way clinicians operate, opening doors to advancing medication in a different way.
“Biosimilars have made their way into the offices of gastroenterologists, rheumatologists, and dermatologists,” says Dr. Neeraj Nurula, Associate Professor of Medicine at McMaster University.
By lowering the price and, therefore, the barrier to entry, biosimilars have helped increase the number of patients who are able to experience these advancements. From those facing inflammatory arthritis to cancer, “the body of evidence that has examined outcomes for patients who’ve switched from a reference biologic to a biosimilar hasn’t demonstrated any difference in outcomes to those who continued with the originator,” says Dr. Nurula.
Biosimilars aren’t the endgame. They’re merely a means of ensuring Canadians have ongoing access to innovation and treatment improvements. For example, in rheumatology, clinicians see the benefits of biosimilars first hand. Biosimilar TNF Inhibitors, which are commonly used in the treatment of conditions like rheumatoid arthritis, are helping pave the way for new and innovative drugs in the space.
A new era of innovation
“Biologics are expensive and make up a huge proportion of Canada’s health-care budget,” says Dr. Lacaille, noting that in 2018, biologics were responsible for nearly $8 billion and 23 per cent of total spending.
Biologics themselves remain an important part of the health-care system. Over time, biologics can lose their effectiveness, and some patients may not respond to the biologics available. “We need the diversity of biologic agents, so we have options for patients who need them,” says Dr. Lacaille.
Relying on biosimilars as replacements for originators helps the health-care system afford the new, innovative biologics that are being discovered every day; drugs that may offer different benefits.
Transitioning to biosimilars paves the way for substantial potential cost savings for the Canadian health-care system — estimated to be anywhere from $332 million to $1.8 billion. The idea is that, with these savings, the system can afford biologics coming to market.
“While there is no medical reason to switch a patient from their current originator biologic to the biosimilar of that product, there are cost savings – equal value for less cost”, says Dr. Janet Pope, rheumatologist at St. Joseph’s Health Centre and a Professor of Medicine at Western University. She adds, “Most if not all biosimilars have similar programs to help patients, so the best way to institute cost savings with biosimilars is to mandate switches if patients are on the originator that has a biosimilar approved.”
Speak to your physician to find out if a biosimilar is right for you.
This page was sponsored by one of Canada’s leading research-based pharmaceutical companies.
