Biosimilars

The biosimilars month in review reflects ongoing efforts to address key challenges in rheumatic disease treatment.

The current approval is based on the VOLTAIRE-HCLF clinical trial, which examined the bioavailability of high-concentration (100 mg/mL) and low-concentration (50 mg/mL) formulations of adalimumab-adbm.

At the end of the trial, the study met its primary outcome, indicating therapeutic equivalence between the biosimilar (AVT05) and reference golimumab.

The FDA approved ustekinumab-aekn for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.

Fresenius announced the immediate availability of its tocilizumab biosimilar, tocilizumab-aazg (Tyenne), in the US.

A new study showed secukinumab was not superior to Sandoz adalimumab (SDZ-ADL; TNF inhibitor) in terms of similar low rates of radiographic progression and safety profiles.

The proposed insulin glargine biosimilar (Basalin) showed comparable immunogenicity, efficacy, and safety to the originator (Lantus) in a phase 3 equivalence trial.

Experts talk about the impact of the launch of adalimumab biosimilar on their clinical practices and pharmacy.

A new study provides insight into the effectiveness of IFX-dyyb in a real-world US population of RA patients, showing how the biosimilar compares to other treatments.

A number of biosimilar options to treat the common retina diseases are in development globally. Here’s a highlight of 9 with supporting late-stage data.

Findings highlight the safety and efficacy of switching from originator to biosimilar adalimumab, which also showed favorable results in adalimumab-naïve patients with IBD.

Specialists in rheumatology, dermatology and gastrointestinal disease discuss clinical trials that have shown safety and efficacy of adalimumab biosimilars in inflammatory diseases.

A clinical pharmacist reviews the various pharmacological aspects of the available adalimumab biosimilars.

Clinicians advocate for an at-parity approach to biosimilars, in which they, their patients, and the local market would have the freedom to choose the product that best suits their needs.

In March, FDA approved biosimilar versions of established biologic drugs for autoimmune diseases and skeletal-related events, adalimumab biosimilars demonstrated sustained efficacy and acceptance among patients, and affirmed CT-P41’s potential as an alternative treatment options in clinical practice.

Clinicians and a pharmacist provide an overview of the emerging adalimumab biosimilars in the recent years.

Drs Lio, Botsoglou, and Axelrad discuss the need for biosimilars in inflammatory diseases, and clinical pharmacist Dr Humphreys reviews the regulatory requirements for biosimilars to receive FDA approval.

The biosimilar recombinant human growth hormone, somatropin, was found to be well-tolerated; only 1.6% of pediatric patients had adverse events suspected to be caused by the injection.

Jon Martin, US Commercial Lead of Biosimilars at Organon, discusses the decision to select biosimilar adalimumab-bwwd and its potential implications on the pharmaceutical market.

The drug is the first tocilizumab biosimilar with an FDA-approved intravenous and subcutaneous formulation.

Patients who were naïve to adalimumab tended to switch to other targeted therapies, while those who had been previously treated with adalimumab were more likely to switch back to the reference product.

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.