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Bones, Muscles & Joints

From Biologics to Biosimilars: The Art of Equivalence

senior woman consulting with doctor
senior woman consulting with doctor
Dr. John Esdaile

Dr. John Esdaile

Scientific Director, Arthritis Research Canada

Dr. Neeraj Narula

Dr. Neeraj Narula

Director, IBD Clinic, McMaster University & President, Canadian IBD Research Consortium

Dr. Janet Pope

Dr. Janet Pope

Division Head in Rheumatology, St. Joseph’s Health Centre & Professor of Medicine, Western University

Drugs derived from complex biological sources, known as biologics, have been in use for over a century, but with recent advances in genetic technology, the field has exploded.

As patents on some biologics expire, pharmaceutical companies are bringing their own, less costly versions of these treatments, known as biosimilars, to market.

Different but equivalent

Biosimilars, by definition, aren’t perfect molecular copies of the drugs they mimic. The validation standards for similarity, however, are very high. “The biosimilar molecules must be demonstrated to have the same basic protein structure, with only minor folding or side-chain differences,” says Dr. Janet Pope, a rheumatologist at St. Joseph’s Health Centre and a Professor of Medicine at Western University. The onus of responsibility is on drug manufacturers to demonstrate that minor differences between biosimilars and the original biologic won’t affect patient treatment outcomes, meaning that health care providers can have confidence in the safety and efficacy of the biosimilar. Moreover, according to the Patented Medicine Prices Review Board, the use of biosimilars can save the Canadian health care system approximately $1.8 billion per year.

As they come to market, biosimilars are providing new options for treating a wide variety of conditions, including ulcerative colitis. “Characteristic symptoms of ulcerative colitis include rectal bleeding, reduced stool consistency, and increased frequency and urgency of bowel movements,” explains Dr. Neeraj Narula, Director of the IBD clinic at McMaster University and President of the Canadian IBD Research Consortium. “Biologics have changed the landscape of ulcerative colitis and are very effective therapies. Biosimilars are effective and they work in the same fashion as the originator molecule, so I don’t have concerns when using biosimilars for patients in need of biologic therapy.”

More choices, better outcomes

Rheumatology is another field of medical care where biologics and biosimilars are changing the treatment landscape. Biologics have proven to be very effective in managing severe cases of rheumatoid arthritis, and some of the first biosimilars to be approved in Canada were indicated for arthritis. As a result, rheumatologists have been on the front lines of patient concerns about switching.

“There was a time when the public and some physicians didn’t understand that generics would save a lot of money without putting someone at risk,” says Dr. John Esdaile, Scientific Director of Arthritis Research Canada. “Those on a chronic prescription for a drug often don’t notice when they’re being switched back and forth among the generics. No one thinks much about this anymore. The main difference today is that the injection system to administer a biosimilar is different from the originator’s. In the future, we’ll talk of biogenerics and no one will care. Both the rheumatologist and their pharmacist will be knowledgeable about the topic and help their patient make the transition.”

Biosimilars are expanding the breadth of treatments available to patients and health providers in rheumatology, ulcerative colitis, and many other medical disciplines, but there remains a need for public education. It’s essential that patients taking or considering biologics have an informed dialogue with their doctors about biosimilars and whether they may be a wise option in their personalized treatment plans.

Biologics, Biosimilars, and Inflammatory Arthritis

What is inflammatory arthritis (IA)?

IA is a group of conditions wherein the body attacks healthy tissues, particularly around the joints, causing inflammation. Inflammation can also cause stiffness and, if left untreated, can lead to significant, irreparable damage. IA can also cause inflammation in the lungs, eyes, heart, and arteries. This can lead to cardiovascular disease, chronic pneumonia, vision loss, and/or premature death.

What are biologics?

Biologics are treatments derived from living cells that target a specific molecule. They’re not made from synthetic chemicals.

What are biosimilars?

Biosimilars are treatments made after a biologic’s patent expires. Any differences between a biosimilar and its reference biologic drug don’t result in differences in safety or efficacy.

Both biologics and biosimilars treat

Rheumatoid arthritis
Ankylosing spondylitis
Psoriatic arthritis
Juvenile arthritis

By 2035, 1 in 4 Canadians will have arthritis

6 million Canadians live with arthritis

Health Canada’s rigorous approval process means that patients can have the same confidence in the quality, safety, and efficacy of a biosimilar as any other biologic drug. Structural, functional, and human clinical studies must demonstrate that there are no clinically-meaningful differences.

Overall, biosimilars offer more choice for people living with IA. The first step to discussing whether a biologic or biosimilar is the right course of treatment starts with a conversation with your rheumatologist.

Source: Health Canada, CAPA

This page was sponsored by one of Canada’s leading research-based pharmaceutical companies.

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