An Update Review of Biosimilars of Adalimumab in Psoriasis – Bioequivalence and Interchangeability

Abstract

Biologic drugs have revolutionized the treatment of psoriasis and other rheumatological diseases. In recent years, many biosimilar agents that are highly similar in structure and function to their originator products have been developed, including the tumor necrosis factor-alpha antagonist adalimumab. The considerably lower cost of these products has greatly cut the economic burden of the patients and increased the accessibility of biologic therapies worldwide. The US Food and Drug Administration and/or the European Medicines Agency have approved eight biosimilars of adalimumab (ABP 501/BI 695501/SB5/GP2017/ FKB327/MSB11022/PF-06410293/CT-P17) for the treatment of psoriasis, and others are under review. Given that these agents showed pharmacokinetic, efficacy, safety, and immunogenicity profiles comparable to those of the originator, adalimumab biosimilars were licensed for all indications approved for reference adalimumab based on extrapolation; however, some of the equivalence studies were only conducted in one or two disease populations. This review discusses the bioequivalence of adalimumab biosimilars as demonstrated by various clinical trials, the extrapolation of indications, guidance and policies of the EU and US on interchangeability (nonmedical switching/automatic substitution) between biosimilars and originators, and the real-life practices of switching from reference adalimumab to the respective biosimilars. Further data from real-world studies and post-marketing analyses are needed better to address the efficacy and safety of the transition strategy.

Secukinumab Loss of Efficacy Is Perfectly Counteracted by the Introduction of Combination Therapy (Rescue Therapy): Data from a Multicenter Real-Life Study in a Cohort of Italian Psoriatic Patients That Avoided Secukinumab Switching

“…Thus, interclass switching is a limited option and intraclass switching increases the failure rate configure the actual scenario of progressive implementation of multifailure patients [42,43]. Furthermore, biosimilars are different drugs from the originator but a failure with the originator may implies a potential failure also with the related biosimilar [44,45].…”

The role of diet in the management of psoriasis: a scoping review

“…(2019) (78) Cross-sectional PLwP N/A Psoriasis severity was lower in participants with greater adherence to the Mediterranean diet for all measurements, PASIp = 0•007, BSAp = 0•009, PGAp = 0•01, subjectivep = 0•004. PREDIMED 14 (79) Review and meta-analysis N/A N/A A gluten-free diet may potentially be beneficial in patients with coeliac antibody-positive psoriasis, but additional studies are needed to confirm this. Michaëlsson et al…”

“…However, satisfaction and adherence to some treatments are suboptimal due to side effects and dissatisfaction with the time taken and degree of improvement (1,12,13) . Long-term efficacy of psoriasis treatments has also been highlighted as a concern (14) . Psoriasis imposes a significant economic burden, which increases with the number and onset of psoriasis-related comorbidities (15,16) .…”

Real-Life Effectiveness of Adalimumab Biosimilars in Patients with Chronic Plaque Psoriasis

“…The biological properties of biosimilars in terms of pharmacokinetic and pharmacodynamic features and immunogenicity are comparable to the originator [ 5 ]. The US Food and Drug Administration and/or the European Medicines Agency have so far approved several adalimumab biosimilars, including MSB11022 (Idacio), ABP501 (Amgevita), SB5 (Imraldi), BI695501 (Cyltezo), GP2017 (Hyrimoz), FKB327 (Hulio), PF06410293 (Amsparity/Abrilada), and CTP17 (Celltrion) [ 6 ]. The real-life effectiveness of adalimumab biosimilars in patients with psoriasis has rarely been investigated [ 7 ].…”