If a particular treatment is working, it’s important to stay the course and continue with what is effective.

Sometimes that is a challenge with the introduction of subsequent entry biologic (SEB) drugs, which may be prescribed in place of an innovator biologic. Biologics are difficult to copy exactly, as a result of their complexity and the cell culture systems used to manufacture them. Therefore, SEBs can be developed that are highly similar to the innovator biologic, but not identical to it. As a result of these differences, Health Canada does not support automatic substitution  of a SEB and the reference product. 

“There’s a lot of comfort that comes from having a patient support program offered by the originator."

Invaluable support systems

Brian Newhook, a naval architect from Whitbourne, Newfoundland, was just 33 years old when he was diagnosed with psoriatic arthritis, a debilitating form of inflammatory arthritis, that left him barely able to walk and in constant pain. As an active father of two (ages one and four years), it was a distressing diagnosis. He could no longer do the things he loved, including playing with his children.

After meeting with his rheumatologist, he was prescribed what’s called an innovator biologic. It was not just the drug Newhook received but the wealth of knowledge and patient support that comes along with an innovator biologic.
At a biologics’ clinic in St. John’s, Newhook was taught how to give himself an injection of the drug with help from his nurse practitioner. With her guidance and monitoring, he has been able to control the disease and reclaim his life. “If I could stay like this, the rest of my life, I’d be happy,” he says. “It’s amazing the difference this drug and my experience at the clinic has made.”

The importance of consistency in care

Some patients have had to switch to an SEB, for example, by their employer’s health plan.

“When asked how they would feel about having both a drug and a support team change, some patients have said they would be very upset and concerned,” says Dr. William Bensen, a Clinical Professor in the Division of Rheumatology at McMaster University and St. Joseph’s Healthcare Hamilton.  After years of successful disease management, patients who have been going to these clinics to get injections and/or infusions of biologics, suddenly lose their trusted support systems.

Gone is the staff that knows them, along with all their expertise, because they were prescribed an SEB. Patients may have to go to a different clinic, in a different city. That is potentially unsettling to people struggling with an illness.
Other doctors cite the need for consistency not just for the physical health of patients, but also for their emotional well-being. “There’s a lot of comfort that comes from having a patient support program offered by the originator,” says Dr. Jane Purvis, Past President, Ontario Rheumatology Association and a rheumatologist in private practice in Peterborough, Ontario. “They do a lot for people. Nurses and the rest of the support team including reimbursement specialists get to know patients and are backed by a wealth of resources. Doctors do not want stable patients switched from one product to another and definitely not back and forth, which can cause confusion and muddies the water.”

Patient choice matters

Every patient should have a say in how their medical condition is treated. It’s a basic right. Yet patients may be put on SEBs — without their knowledge. They should ask their doctors whether they are being prescribed an originator drug, or an SEB.

According to Dr. Neil Shear, the Chief of Dermatology at Sunnybrook Health Sciences Centre and University of Toronto: “Patients need to be well informed and understand the difference between subsequent entry biologics and innovator biologics for them to make an informed decision.”

And he adds, “Whatever happens, I strongly believe that once a patient is stabilized on a drug, then they should stay on that biologic”.