Giezen Abstract Background Patients in clinical practice are transitioned from originator etanercept (OR-ETA) to biosimilar etanercept (BS-ETA), but some subsequently retransition.

medwireNews : The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new etanercept biosimilar for the treatment of a number of rheumatic diseases.

By Claire Barnard m edwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group See also: International recommendations for the use of biosimilars issued Equivalence of GP2015, etanercept demonstrated Etanercept biosimilar shows potential for the treatment of RA No worsening in disease activity with switch to biosimilar etanercept

Disease activity does not change following the switch from etanercept to the biosimilar formulation SB4, and treatment retention rates may be determined by patient-specific factors, suggests an analysis of the DANBIO registry.

Disease activity does not change following the switch from etanercept to the biosimilar formulation SB4, and treatment retention rates may be determined by patient-specific factors, suggests an analysis of the DANBIO registry.

Phase III trial results suggest that the etanercept biosimilar LBEC0101 has comparable efficacy and safety profiles to its reference product in patients with active rheumatoid arthritis despite methotrexate treatment.

Methods Drug administration intervals and disease activity indexes in patients with AS who regularly used etanercept (ETN) biosimilars for more than 1 year and those who withdrew the drugs during the same period in a single center were analyzed retrospectively.

“We so far have not benefited from the use of primarily biosimilar anti-TNFs [in the USA], but in Europe the [annual] cost of adalimumab biosimilar or etanercept biosimilar is about US$ 5000 [€ 4243],” whereas JAK inhibitors in the USA cost $ 50,000–60,000 (€ 42,436–50,923), “so there is a major cost saving with biosimilars,” he said.

And in the safety analysis, certolizumab pegol was associated with a significantly greater risk for infection compared with abatacept, anakinra, etanercept, golimumab, and tocilizumab (RR=1.35–1.53).

For instance, the infliximab biosimilar CT-P13 was approved by the EMA in 2013 and by the US FDA in 2016, with a number of approvals following in 2016–2017, including the etanercept biosimilar GP2015 and the adalimumab biosimilar ABP 501.

Findings from the EQUIRA trial suggest that the etanercept biosimilar GP2015 has similar efficacy and safety profiles to its reference product.

William Tillett, Deepak Jadon, and Jobie Evans debate the clinical reasons relating to the efficacy, safety, and practicality of using etanercept or methotrexate as first-line therapy for psoriatic arthritis.

However, as the first generation of biologic anti-TNF “originators” have come off patent, biosimilars of infliximab, etanercept, and adalimumab have emerged, with a corresponding improvement in cost-effectiveness.

Two follow-up analyses of a randomized trial suggest that the etanercept biosimilar SB4 and its reference product have similar long-term efficacy and safety profiles in patients with rheumatoid arthritis, and switching to the biosimilar is not associated with adverse events or loss of response.

medwireNews  provides an overview of the evidence supporting the equivalence of biosimilar drugs and their reference products, and answers some questions about the use of biosimilars in rheumatology.

The analysis included 20 randomized controlled trials of six TNF inhibitors – adalimumab; certolizumab pegol; etanercept; golimumab; infliximab; and the infliximab biosimilar CT-P13 – involving 3220 AS patients with a mean age of 27.4 to 48.0 years.