Biosimilars

The decision was based on clinical studies demonstrating no clinically meaningful differences between the biosimilar and its reference product.

The primary endpoint was achieved, with biosimilar CT-P41 demonstrating comparable pharmacokinetics.

This month’s biosimilars month in review highlights the evolving landscape of biosimilars, emphasizing their potential benefits in terms of safety, cost-effectiveness, and increased treatment options, while recognizing the importance of addressing challenges in adoption and perception.

Inflammatory markers, infliximab levels, and physician global assessment scores remained similar when assessed pre- and post-switch to an infliximab biosimilar.

The approval was based on clinical data from 3 multicenter, randomized trials which demonstrated the safety, efficacy, and biosimilarity of adalimumab-ryvk compared with the reference product.

Of those who received an infliximab biosimilar, 87.8% were maintained on a single biosimilar without the need to switch to an alternative product.

Unlike several European countries, Brazil does not have recurring price reductions, which could contribute to the distorted prices for biological medicines.

Nearly half (47%) of biosimilar users knew they were using biosimilars but 31% thought the medicine was an originator. In contrast, 80% of originator users knew they were using an originator, and none thought they were using a biosimilar.

In a phase 3 trial in China, QL1207 demonstrated equivalent efficacy to aflibercept with a similar safety profile for patients with nAMD.

Clinical equivalence was demonstrated for the primary and key secondary endpoints between patients receiving MSB11456 and its reference drug, tocilizumab.

Patients who switched from originator adalimumab to a biosimilar experienced more treatment-emergent adverse events compared to those who stuck with the biosimilar or the reference drug.

SARS-CoV-2 antibody levels did not change significantly in patients receiving originator adalimumab, while patients receiving the biosimilar experienced a significant decrease.

Patients with rheumatic disease treated with biosimilar SDZ ETN reported high treatment persistence at month 12 as well as comparable safety and efficacy.

The biosimilars month in review explores the efficacy and safety of biosimilars in treating uveitis, highlights the FDA’s acceptance of a biologics license application for an ustekinumab biosimilar, and emphasizes the safety and accessibility benefits of biosimilars in rheumatic conditions.

Patients with uveitis switched from adalimumab originator to SB5 did not experience clinically significant differences in treatment efficacy and safety.

A significantly larger proportion of patients receiving the biosimilar QL0911 achieved a durable platelet response when compared with placebo.

Real-life data reveal the effectiveness of TNF-inhibitor biosimilars in minimizing ocular flares and preserving visual acuity in pediatric patients with uveitis.

Results showed no differences regarding safety, although the biosimilar group had slightly more discontinuations due to inefficacy.

Test your knowledge of treatment persistence, adherence, and switching patterns of adalimumab biosimilar ABP 501 between adalimumab-naïve patients and adalimumab-experienced patients.

BIOS-ROP study results indicate the bevacizumab biosimilar monotherapy leads to complete ROP regression in almost two-third of the eyes after 24 weeks of treatment.

During a 10-year period, estimated access to drugs increased among Polish patients with rheumatic and musculoskeletal diseases.

BLA submission was based on data from phase 3 clinical trials in which DMB-3115 showed no clinically meaningful differences compared with the reference product for the treatment of plaque psoriasis.

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.