FROM BIOLOGICS TO BIOSIMILARS: THE ART OF EQUIVALENCE
Biologics have changed the face of medicine. These drugs — derived from complex biological sources — have been with us for more than 100 years, but advances in genetic technology have seen the field explode in recent decades. As patents on some biologics begin to expire, pharmaceutical companies are bringing their own, cost-effective versions of these treatments, known as biosimilars, to market. Health Canada approved the first biosimilar to treat inflammatory arthritis in 2014, and with biosimilars becoming more integrated in the Canadian health care system, now is a good time for patients to learn more about them.
Different but equivalent
Biosimilars, by definition, are not perfect molecular copies of the drugs they mimic. They go through a complex production process and the validation standards for similarity are exacting. “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 Care and a professor of medicine at Western University.
“We have data from head-to-head comparisons showing that the results for patients are statistically equivalent and they are as similar as the batch-tobatch variation of the innovator molecule.”
The onus of responsibility is on drug manufacturers to demonstrate that differences between biosimilars and the original drug will not affect patient treatment outcomes meaning health care providers can have confidence in the safety and efficacy of the biosimilar as with any other biologic drug. The costs associated with them are lower than those of biologics, which is a clear advantage for patients as treatment costs are on the rise. Moreover, according to the Patented Medicines Pricing Review Board, the use of biosimilars can save the Canadian health care system approximately $1.8 billion per year.
More choices, better outcomes
Rheumatology is one of the first medical communities to see results with both types of drugs. In fact, biologics have proven to be extremely effective in managing the most severe cases of rheumatoid arthritis (RA).
“Biologic therapies have revolutionized the treatment of RA,” says Dr. Bindee Kuriya, Director of the Rapid Access Rheumatology Clinic at Mount Sinai Hospital. “At the same time, biosimilars are effective and they work in the same fashion as the originator molecule, so we are quite happy to start a biologic-naïve patient on a biosimilar.” Some public and private drug plans in Canada may be considering implementing policies which include the switch from biologics to biosimilars because of their welldemonstrated safety and efficacy.
Biosimilars are expanding the choices available to patients and health care providers in rheumatology and many other medical disciplines, but with greater choice comes a greater need for public education. That’s why it’s essential that patients taking or considering biologics have an informed dialogue with their doctors about biosimilars and whether they may be an option in their personalized treatment plans.
“Biosimilars are expanding the choices available to patients and health care providers.”