Biosimilars

This new analysis on IBD patients initiating biologic therapy with the biosimilar ABP 501 indicates that the drug’s lower cost and efficacy may lead to greater use.

Pharmacokinetic exposure of the biosimilar insulin and reference product showed similarity, supporting the interchangeability between the two insulin aspart products.

In a new pooled analysis of 3 pharmacokinetic studies, the investigators confirmed the bioequivalence, safety, and immunogenicity between biosimilar MB02 and European Union approved bevacizumab and US-approved bevacizumab.

The biosimilars month in review highlights top data demonstrating the efficacy of biosimilars for treating inflammatory bowel disease and plaque psoriasis, as well as trends in adopting biosimilars among patients and clinicians in the US.

A single-center cohort analysis showed the biosimilar provided similar PBSC mobilization to originator filgrastim.

There was no statistically significant difference in postoperative thromboembolic events and incident heparin-induced thrombocytopenia among patients treated with branded versus biosimilar enoxaparin.

Aotearoa, New Zealand had a mandatory adalimumab biosimilar transition from March – September 2022. A survey reveals low satisfaction with biosimilar’s quality, as well as the lack of alcoholic wipes and a support program.

Results showed similar rates of treatment persistence between the groups, with further analysis calling attention to a 40% price reduction in the cost of treatment in Australia due to reference pricing policies between biosimilars and originators.

Russell D Cohen, MD, explains how biosimilars represent an opportunity to expand access and reduce the financial burden of high-cost biologics.

Data from a phase 3 trial of CT-P43 in patients with moderate to severe plaque psoriasis offers additional insight into the comparative effects of the biosimilar relative to ustekinumab.

Results of the COMPACT study detail persistence rates, QoL data, and efficacy of biosimilar etanercept among patients in real-world settings.

This is the first research to allow for greater insight into the impacts on providers of a nationwide change to an adalimumab biosimilar.

This study provides further support for the efficacy of this biosimilar, allowing for potential future reduction in costs for patients with IBD.

An analysis of national Canadian data suggest patients receiving either originator or biosimilar infliximab are at a similar risk of the common adverse event.

Most patients with active Crohn’s disease receiving adalimumab biosimilar, HS016, achieved clinical response at weeks 12, 26, and 52.

This new research opens the door for further biological agent use in IBD therapy, helping to expand patients’ array of options when seeking IBD treatment in different countries.

Analysis shows the rate of use with the originator biologic has decreased from 90% in 2016, to 19% in 2021.

Trial data support multiple switching between biosimilar and reference product over a 48-week course for the treatment of psoriasis.

Very few patients switch off a biosimilar due to adverse effects, according to a new study.

David Charles, MD, chief medical officer of the Alliance for Patient Access, delves into the far-reaching implications of alternative funding programs.

The FDA announced the approval of ustekinumab-auub (Wezlana) as a biosimilar and interchangeable to ustekinumab (Stelara) for a half dozen inflammatory conditions on October 31, 2023.

A new study indicates biosimilar trials remained consistent from 4-6 months through 12 months, which investigators suggest indicates these trials could be shortened without affecting safety and efficacy profiles.

The post-hoc analysis of a phase 3 clinical trial suggests SB15 has comparable clinical efficacy and safety to aflibercept in patients with nAMD.

Patients with UC and Crohn's disease showed higher drug levels and good acceptance when switching from intravitreal to subcutaneous infliximab.

Experts recommended the early use of anti-TNF therapy for patients with ulcerative colitis and Crohn disease, offering further input regarding the introduction, optimization, and maintenance of the treatment for patients with IBD.

Switching from biosimilar CT-P13 to SB2 is safe and effective, according to new research. The patients in the study had no significant changes in their psychometric assessments during the 12 month follow up.

Findings from the phase 1 study informed the clinical development program for GP40141 as a biosimilar treatment for ITP, demonstrating pharmacodynamic similarity to reference romiplostim.

SB16, a denosumab biosimilar, demonstrated pharmacokinetic and pharmacodynamic comparability with reference denosumab in a phase 1 trial in healthy male adults.

Samsung Bioepis gains FDA interchangeability designation for its ranibizumab (Lucentis) biosimilar, ranibizumab-nuna (Byooviz), in the treatment of wAMD, macular edema following RVO, and mCMV

Study finds the biosimilar ABP 654 and ustekinumab do not have clinical meaningful differences according to the step-wide totality-of-evidence approach and thus have similar psychochemical and biological properties.