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Biosimilars Seen as Safe, Effective Compared With Reference Biologics
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Recently published results showed biosimilars used to treat rheumatoid arthritis, inflammatory bowel disease and psoriasis are as safe and effective as reference tumor necrosis factor-alpha inhibitors.
“Biologic treatments represent a rapidly growing proportion of prescription drug expenditures, and thus, there is enormous interest in whether or not biosimilar products are truly biosimilar,” G. Caleb Alexander, MD, co-director at the Johns Hopkins Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health, told Healio.com/Rheumatology. “Our results suggest that, for this important class of drugs, the biosimilar versions appear to have the same safety and efficacy profiles as their branded counterparts (or as the originator products).”
G. Caleb Alexander
Alexander and colleagues analyzed 19 studies to compare biosimilars and reference tumor-necrosis factor-alpha (TNF-alpha) inhibitors used to treat rheumatoid arthritis, inflammatory bowel disease and psoriasis. Overall, eight studies were phase 1 randomized trials, five studies were phase 3 randomized trials and six studies were observational, according to researchers.
Results showed the prespecified equivalence margin of 80% to 125% was met by the pharmacokinetic parameters of the biosimilar and respective biologic in all phase 1 trials. Researchers noted clinical responses and adverse events were similar between the treatments in phase 3 trials, with adverse events usually of mild to moderate severity. Cross-reactivity was found between products in two cross-sectional observational studies, according to results. Researchers found similar efficacy and safety outcomes in four cohort studies in which patients were switched from reference to biosimilar products.
“These findings are big news because TNF-alpha inhibitors are a costly and commonly used class of biologics, [and] it has not been clear whether TNF-alpha biosimilars are as safe and effective as their branded counterparts,” Alexander said. – by Casey Tingle
Disclosure: Alexander reports no relevant financial disclosures.
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Chingcuanco F, et al. Ann Intern Med. 2016;doi:10.7326/M16-0428.
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