Two etanercept (Enbrel) biosimilars have been approved in the United States, but neither has yet been released because patent litigation prevents them from reaching the market until 2029. However, once it hits the market, it is expected to become widespread like other biosimilars. Launched products reduce the cost of experience reference products.
Enbrel's global sales exceeded $4 billion in 2022. Two biosimilars have been approved in the United States, but neither will be released until 2029 due to patent litigation.
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Although Enbrel does not bring in as much revenue as Humira, which won competition from eight biosimilars in 2023, Sales in 2022 will exceed $4 billion, there is a significant opportunity for cost reduction as lower-cost alternatives come to market. Additionally, in the United States, Enbrel is listed as one of 10 drugs selected by CMS for Medicare price negotiation under the Inflation Control Act.
In Australia, the first etanercept biosimilar, Brenzys, has been launched. now available Since 2016, we have seen similar treatment continuities between originators and biosimilars, as well as cost reductions due to government pricing policies, tying new drug prices to similar safety and efficacy to reduce costs. According to a real-world report – Global Effectiveness Study was announced on internal medicine journal.
“Once a biosimilar is listed, governments take measures such as legal price reductions and price disclosure to benefit from the competition generated by biosimilars, resulting in lower prices for both the original drug and the biosimilar. “decreases,” the authors explained. “This increased competition between comparable products has led to cost reductions, making biosimilars an important tool in managing Australia's rising healthcare costs.”
Optimizing Patient Outcomes in Rheumatology Using data from the Australian real-world dataset, researchers compared treatment persistence (as a surrogate for treatment efficacy) of the reference product and Brenzies, a biosimilar of etanercept. use) was evaluated.
The database identified 53,526 patients with rheumatoid arthritis, of which 1,153 eligible patients had their first documented biological or targeted synthetic disease-modifying disease between April 1, 2017 and December 31, 2020. The patient was receiving an original product or a biosimilar anti-rheumatic drug (b/tsDMARD). Only 386 of his patients had a 3-month follow-up. Overall, 350 patients were matched. 209 people were treated with the originator and 141 with the biosimilar.
The median time from baseline until half of the patients discontinued treatment was slightly longer for the biosimilar in the matched population (19.4 months vs. 22.4 months). Of the total eligible population, 10.1% of patients taking the originator and 14.5% of patients taking the biosimilar discontinued treatment due to side effects.
Prior to the introduction of biosimilars, the estimated cost of treatment for the entire eligible population assuming a standard dose would be approximately AU$23,982,400 (approximately US$16,063,411). Due to Australian pricing policy, the biosimilar listing has reduced the price of etanercept by 40%. The cost of treating the entire eligible population one year after biosimilar introduction was an estimated AU$14,389,440 (approximately US$9,638,046). As a result of government policy and the introduction of biosimilars, cost savings for the Australian Government were AU$9.5 million (US$6.3 million).
Additionally, the researchers noted that although switch rates from originator to biosimilar drugs were low, Australian rheumatologists increasingly chose to prescribe biosimilars during the study period, and the authors speculate that this may reflect the wishes of rheumatologists and patients. Maintain existing treatment if response is good and disease is stable, or continue existing treatment if patient responds poorly and wishes to try alternative therapy. [tumor necrosis factor inhibitor] Alternatively, you can target another mechanism. ”
However, this study only included patients who started etanercept in the first-line setting, so it is possible that some patients may have been taking the originator product before the biosimilar was available or that a switch may have occurred. It added that sexual patients were not evaluated.
One of the limitations of this study was that its observational nature made it vulnerable to missing data and lack of randomization.
reference
Deakin CT, Littlejohn GO, Griffiths H, et al. Opal Consortium. Comparing the efficacy of originator and biosimilar etanercept in the treatment of rheumatoid arthritis: Implications for cost savings. Intern Medicine J. Published online on November 27, 2023. doi:10.1111/imj.16296
