Highlights from

SPIN 2019

Skin Inflammation & Psoriasis International Network

Paris 25-27 April 2019

ABP501 Biosimilar for adalimumab: What you need to know

Prof. Brian Kirby (St Vincent's Hospital, Dublin, Ireland) presented convincing data with regard to biosimilar ABP50 efficacy and safety in psoriasis patients vs adalimumab. He began by reminding the audience that the development of targeted and effective biological therapies has transformed the outcomes for patients with psoriasis [1]. 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 through the use of 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), so there were ABP501/ABP501 (n=152), adalimumab/adalimumab (n=79), and adalimumab/ABP501 (n=77) that were followed for a year. Switching made no difference whatsoever (mean % PASI change was identical), showing identical efficacy and safety profiles, but at significantly reduced costs.

  1. Kirby B. Psoriasis. FS02, SPIN 2019, 25-27 April, Paris, France.
  2. Santos SB, Sousa Lobo JM, Silva AC. Biosimilar medicines used for cancer therapy in Europe: a review. Drug Discov Today. 2019 Jan;24(1):293-299.
  3. QuintilesIMS Report 2017. Retrieved from: https://ec.europa.eu/growth/content/impact-biosimilar-competition-price-volume-and-market-share-update-2017-0_en [Accessed 25 April 2019]
  4. Moorkens E, et al. Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies. Front Pharmacol. 2016 Jun 29;7:193.

The content and interpretation of these conference highlights are the views and comments of the speakers/authors.