Presenters to Review Real-World Evidence Supporting Biosimilar Use

Biosimilars have been approved and marketed for the better part of a decade. Real-world evidence shows that safety, efficacy, and outcomes are similar between biosimilars and their originator compounds.

“When these drugs were first licensed, there was a lot of anxiety among healthcare providers and patients about their use, particularly for patients who had been established on originators and doing very well,” said Kimme Hyrich, MD, PhD, Professor of Epidemiology at the Centre for Epidemiology Versus Arthritis, The University of Manchester, United Kingdom. “Biosimilars do have significant advantages, the largest being cost. The cost savings for the UK National Health Service, by switching to biosimilars, has been tremendous and can support investment in other areas.”

Dr. Hyrich will discuss the British experience in healthcare utilization and switching between biosimilars and originators during Biosimilars: Are They Biobetter? on Monday, Nov. 18, from 10:30–11:30 a.m. ET in Ballroom A of the Walter E. Washington Convention Center. The session will be available on demand within 48 hours for registered ACR Convergence 2024 participants.

Jonathan Kay, MD, Professor and the Timothy S. and Elaine Peterson Chair in Rheumatology at the University of Massachusetts T.H. Chan School of Medicine, will discuss the U.S. experience in biosimilars. Diane Lacaille, MD, Scientific Director and Senior Scientist at Arthritis Research Canada, and Professor and the Mary Pack Chair in Rheumatology Research at the University of British Columbia, Canada, will review the latest Canadian findings.

British Columbia was the first Canadian province to authorize biosimilars and mandate biosimilar use when available. Administrative data show no significant difference between biosimilars and originator compounds in survival on treatment, how long patients stay on treatment, or as a marker for efficacy and safety.

“We found there was no significant difference in either the number of people who started or stopped a new DMARD (disease-modifying antirheumatic drug) between biosimilars and originators,” Dr. Lacaille said. “We found that biosimilars did not have an increase in infection rate or increased rates of utilization of other healthcare services. Biosimilar trends show a very successful adoption process in Canada.”

Moving from a DMARD to a biosimilar is seldom difficult. Moving from an originator to a biosimilar can be. Dr. Hyrich noted that some healthcare settings, public settings in particular, planned wholesale switching to biosimilars, essentially removing patient choice.

“We needed good plans to switch our patients, including communication, and, with time, evidence to show that in a real-world, clinical setting, biosimilars were, indeed, biosimilar,” she said. “Much data in this regard now exists and is very reassuring.”

Dr. Lacaille said communication and buy-in were equally essential as Canada introduced biosimilars. Patients whose disease was uncontrolled on DMARDs and who found relief from a biologic were understandably reluctant to switch medications.

“We cannot underestimate the impact of this transition for patients,” she said. “It is important that we support patients in this transition, that we give a consistent message that we, as healthcare professionals, the rheumatology community, have confidence that these drugs are equivalent. We have to acknowledge that moving to a biosimilar is a big deal.”

Moving to biosimilars is also significant for healthcare systems and payers, which have the opportunity to invest biosimilar cost savings in new generations of agents that come with ever higher price tags.

“Biosimilars are as effective and as safe as originators,” Dr. Lacaille said. “We need to switch in order to be able to offer to patients the emerging new drugs that are coming out and the new discoveries that are coming on the market in the future. Biosimilars are the only fiscally responsible way we’re going to be able to do that.”