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ABP501 biosimilar for adalimumab: What you need to know

Presented by
Prof. Brian Kirby, St Vincent's Hospital, Dublin, Ireland
SPIN 2019
Prof. Brian Kirby (St Vincent's Hospital, Dublin, Ireland) presented convincing data on the efficacy and safety of biosimilar ABP501 vs adalimumab in psoriasis patients [1].

Prof. Kirby began by reminding the audience that the development of targeted and effective biological therapies has transformed the outcomes for patients with psoriasis. Biosimilars are approved by regulatory authorities on the basis of rigorous clinical trials that demonstrate they are highly similar to the reference product in terms of quality, safety, and efficacy [2]. Minor differences in clinically inactive components must be supported by strong scientific evidence that these differences are not clinically meaningful. In general, they have lower acquisition costs than the reference product, and biosimilars have been shown to introduce price competition into the market, leading to reduced prices for the treatment of all patients [3]. Consequently, health authorities are increasing their use of biosimilars [4]. Each nation will develop policies on automatic substitution, automatic switching, and interchangeability. Reducing healthcare expenditure on biologics and releasing cost savings to support improved access to these important medicines by using biosimilars will play a vital role in ensuring that psoriasis patients can receive optimal treatment for their disease. The cost savings from biosimilars can improve patient access by broadening national reimbursement criteria to reach parity with European and other international guidelines. For both patients and healthcare providers, this may offer the benefit of improved clinical outcomes. At week 16, patients were blindly switched (or not). Patients were either on ABP501/ABP501 (n=152), adalimumab/adalimumab (n=79), or adalimumab/ABP501 (n=77), and were followed for a year. Switching made no difference (mean % PASI change was identical), showing identical efficacy and safety profiles but at significantly reduced costs.

    1. Kirby B. FS02, SPIN 2019, 25-27 April, Paris, France.

    2. Santos SB, et al. Drug Discov Today. 2019 Jan;24(1):293-299.

    3. QuintilesIMS Report 2017. Retrieved from: https://ec.europa.eu [Accessed 25 April 2019].

    4. Moorkens E, et al. Front Pharmacol. 2016 Jun 29;7:193.

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