medwireNews : The EMA’s Committee for Medicinal Products for Human Use has recommended subcutaneous CT-P13, an infliximab biosimilar, for approval in Europe.

The EMA’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of a new infliximab biosimilar for the treatment of various types of arthritis.

Using infliximab-dyyb instead of the reference product may not reduce out-of-pocket costs for US rheumatoid arthritis patients insured on the Medicare Part D system, study results suggest.

Using infliximab-dyyb instead of the reference product may not reduce out-of-pocket costs for US rheumatoid arthritis patients insured on the Medicare Part D system, study results suggest.

medwireNews : PF-06438179 (infliximab-qbtx), an infliximab biosimilar, has been approved in the USA for the same indications as its reference product.

A substantial proportion of Dutch patients discontinue treatment with the infliximab biosimilar CT-P13 following transition from the reference drug, researchers report.

Results of two independent studies suggest that patients with inflammatory arthritis can be switched from infliximab to the biosimilar CT-P13 without compromising the effectiveness of treatment.

Marc Cohen analyzes the various economic factors influencing the price of biosimilars over recent years in rheumatology, focusing on the United States healthcare system.

“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.

“This information could be important for clinical practice, considering the changes in treatment strategies for rheumatoid arthritis and the increasing number of biosimilar biological medicines available,” say the study authors in The BMJ .

Estimated remission and retention rates do not differ significantly among patients with rheumatoid arthritis treated with either certolizumab pegol, abatacept, or biosimilar infliximab, show the results of a surrogate randomized controlled trial.

medwireNews : The US FDA has approved a new infliximab biosimilar for the treatment of various types of arthritis.

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.

Results of a phase III trial indicate that the infliximab biosimilar PF-06438179/GP1111 has similar efficacy, safety, and immunogenicity profiles to its reference product.

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.

The similar efficacy, safety, and immunogenicity profiles of the infliximab biosimilar SB2 and its reference product are maintained for up to 54 weeks among patients with rheumatoid arthritis, suggest follow-up results of a randomized clinical trial.

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.