Biosimilars

The biosimilars month in review highlights interviews with experts discussing the cost-saving potential of increased biosimilars uptake in the US, a recent US Food and Drug Administration (FDA) approval, and the impact of a mandatory switch to an adalimumab biosimilar in New Zealand.

Efficacy, pharmacokinetics, immunogenicity, and safety were comparable between patients receiving the aflibercept biosimilar SB15 and the reference drug.

Analysis shows that biosimilar uptake was up to 2-fold greater in Medicare Advantage coverage than traditional Medicare.

Despite a boom of new, cost-efficient options for chronic conditions, prescriber and patient concern over clinical benefit persists.

The decision was based on both clinical and non-clinical data supporting the biosimilarity of bevacizumab-tnjn (Avzivi), previously named BAT1706.

Just more than a month after the FDA approved their first biosimilar to ustekinumab (Stelara), Bio-Thera Solutions announced positive results from their phase 3 trial of BAT2206

These results in the subgroup analysis, seen among individuals who were both identified as Asian and non-Asian, align with data published previously in the overall population.

In an interview with HCPLive, Juliana Reed, MS, explains the pivotal role biosimilars play in healthcare and the barriers to access and adoption.

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.