LAUSR

Biologic medications have revolutionized the treatment of many rheumatologic diseases, but their high cost often limits patient access to these effective treatments. Biosimilars are legitimate copies of biopharmaceuticals, which no longer are protected by patent, that have undergone rigorous analytical and clinical assessment in comparison to their reference products and have been approved by a regulatory authority in a highly regulated area according to a specific pathway for biosimilar evaluation. In 2005, the European Medicines Agency (EMA) established a pathway for the review and approval of biosimilars and, one year later, approved the human growth hormone Omnitrope® as the first biosimilar. As of March 2019, 56 of 60 biosimilars approved by the EMA were commercially available in the European Union, of which 6 were of rituximab and 15 were of TNF inhibitors to treat rheumatologic diseases. Commercially available lots of a reference product are not identical to one another. All biologic medications are subject to normal batch-to-batch variability and are monitored to ensure that this variation is within “proven acceptable ranges” so that patients are not subjected to risks of lesser safety or efficacy. Since biosimilars have been compared extensively to their reference products and been shown to have highly similar structure, equivalent efficacy, and comparable safety, an approved biosimilar can be considered to be like another batch of its reference product. Thus, patients need not be apprehensive about using an approved biosimilar in place of its reference product. The “nocebo effect” refers to the misattribution of bodily symptoms to a medication and may result in discontinuation of a treatment that is not actually causing the perceived symptoms. Studies have suggested that the nocebo effect may result in discontinuation of treatment with a biosimilar because of subjective perceptions. This may be addressed by providing encouragement and reassurance through education and open collaborative discussion between providers and patients. By taking this approach to counseling patients, the rate of biosimilar discontinuation may be reduced. The NOR-SWITCH study demonstrated that patients with inflammatory diseases controlled on treatment with reference infliximab do not experience greater worsening of disease activity when switched to biosimilar infliximab CT-P13 than when continued on treatment with the reference product. Thus, when the cost of the biosimilar is significantly lower than that of its reference product, substituting the biosimilar for the reference product may provide an economic advantage with no loss of clinical benefit. In Norway, where there is an annual “winner takes all” competitive tender process for hospital administered medications, the price of biosimilar infliximab in 2015 was 69% lower than that of its reference product. Thus, in most countries, it is safe, effective, and cost-effective to switch to a biosimilar. However, competition from biosimilars has occasionally driven down the price of a reference product, as in Sweden where the price of reference adalimumab was reduced by 80% in 2018 and became lower than that of adalimumab biosimilars. The availability of lower-priced biosimilars should decrease the cost of treating patients by introducing market competition. Biosimilars should be more readily available to patients for whom the reference product had been inaccessible because of cost. Greater global access to effective biologic medications should reduce disability, morbidity, and mortality associated with rheumatologic diseases. Disclosure of Interests: Jonathan Kay Grant/research support from: Gilead Sciences, Pfizer, UCB Pharma, Consultant for: AbbVie, Boehringer Ingelheim GmbH, Celltrion Healthcare, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals, Pfizer, Samsung Bioepis, Sandoz, UCB Pharma