Biosimilars

The Biosimilars Forum is concerned with the limited access to lower-cost biosimilars, specifically regarding the 8 adalimumab biosimilars set to launch in July, due to pharmacy benefits managers controlling access to 80% of the US market.

Although 75% of gastroenterologists believed that the efficacy of biosimilars and biologics were the same, most clinicians still preferred the brand-name drug option.

Patients who received the biosimilar reported early and significant improvements in areas of pain, NSAIDs requirement, and function.

No significant budget increase was observed in patients with non-radiographic axial spondyloarthritis (nr-axSpA) receiving secukinumab.

Statistical analysis showed no differences between each pairwise comparison of the bevacizumab biosimilars, MB02-SP and MB02-DM, and the reference drug.

Proposed biosimilar AVT04 shows comparable efficacy to ustekinumab.

Clinical remission and clinical response odds, in both induction and maintenance periods, have been consistent over time.

Data from the United Kingdom indicate Amgevita is safe and effective for non-infectious uveitis with non-inferiority to originator adalimumab, but a significant number of patients requested to switch back due to adverse events.

Bruce Feinberg, DO, explained that he and his team at Cardinal Health are constantly examining the market and the various influences that impact biosimilar uptake.

The approval was based on positive results from the phase I pharmacokinetics bridging study, which showed comparable PK and similar safety and immunogenicity of adalimumab 50 mg/mL and adalimumab high-concentration formulation.

In the infliximab reference group, the persistence at month 12 was 94% for Crohn’s disease and 92.8% for ulcerative colitis.

Bruce Feinberg, DO, noted that although patients and providers ultimately understand that a biosimilar should theoretically be just as effective as a biologic, prescribers may still be wary of switching patients to a different product when they have historically experienced an excellent response to the original treatment.

Bruce Feinberg, DO, explained how Cardinal Health used its 2023 Biosimilars Report to better understand the provider's insight on industry changes that are occurring due to the expansion of biosimilars.

No sign of harmful impacts related to the mandatory biosimilar switching policy for patients with inflammatory bowel diseases treated with infliximab was observed in the cohort study.

A recent study found no association between exposure to rituximab biosimilars and hospitalization for hypersensitivity reactions compared to the biologic at initiation, at switch, or over time.

A significant decrease in indirect costs was observed in patients switching from intravenous to subcutaneous CT-P13, which was attributed to lower total costs overall.

No differences in adverse events, including infusion-related reactions, infections, and hypogammaglobulinemia, were reported among patients receiving rituximab and the biosimilar, CT-P10.

Although etanercept biosimilars demonstrated comparable efficacy, safety, and immunogenicity when compared with the reference drug, biosimilar treatment was associated with a better ACR50 response rate.

There was a 0.9% increase in the first dispensation of infliximab, either the biosimilar or originator during the first year of follow-up, as well as a 16.2% increase in infliximab dose escalation, a 2.4% decrease in the dispensation of antibiotics, and a 2.6% decrease in the new use of prednisone.

Research indicates that a potential reduction in healthcare costs could result from utilization of biosimilars for adalimumab and etanercept in dermatology.

A recent study found that the biosimilar MSB11456 showed pharmacokinetic similarity, immunogenicity, and safety profiles comparable to the reference drug, tocilizumab, suggesting that it could be a cost-effective alternative for treating autoimmune disorders.

The clinician experience across specialties is crucial as the biosimilars market in the United States continues to expand.

New data show the FDA's rationale for approving drugs with unmet efficacy end points in pivotal trials has been inconsistent since at least 2018.

Pharmaceutical claims data were collected for the reference drugs and etanercept and infliximab biosimilars to analyze changes in the proportions of dispensed of and total spending on biosimilars after the new start and biosimilar switching policies began.

As similar studies evaluating CT-P17 have not been conducted in Japan, these findings support applying the biosimilarity conclusions from other studies to this patient population.

Investigators sought to analyze adherence, safety, and the clinical outcome in patients treated with the etanercept biosimilar, SB4.

Despite multi-stakeholder information campaigns supporting the use of biosimilars, barriers remain that hinder uptake.

Investigators evaluated whether the availability of the biosimilar infliximab was linked to lower out-of-pocket costs using claims from the IBM MarketScan national data set of commercially insured patients.

In an effort to address unmet needs related to the accessibility of biosimilars globally, the WHO updates the guidelines to include more therapies in the category.