Biosimilars

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.

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.

Sintilimab plus IBI305 showed a significant improvement in objective response rate, time to response, duration of response, and depth of response in unresectable HCC versus sorafenib.

Natalizumab PB006 is the first biosimilar monoclonal antibody developed for treating patients with multiple sclerosis (MS).

There is very little data on long-term outcomes from pediatric patients with inflammatory bowel disease treated with anti-TNF biosimilars.

Adalimumab-atto will be used to treat several inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis.

Risankizumab is the latest biologic approved by the FDA and the first-ever IL-23A targeted therapy approved for the treatment of patients with Crohn's disease.

Real-world evidence indicates that patients with psoriasis can safely and effectively undergo (non-medical) switching to a biosimilar.

Shifts towards on-patient and higher-cost therapies have been observed in TNF-alpha inhibitor biosimilar availability. Therefore, the importance of investing in biosimilars is encouraged.

The safety and efficacy of 4 adalimumab biosimilars was compared in a real-life setting in adult patients with IBD switching from the originator for a non-medical reason.

A phase 4, post-marketing surveillance study in Korea provides insight into the safety and efficacy of SB2, an infliximab biosimilar, across a wide range of immune-mediated inflammatory diseases, including rheumatoid arthritis, ulcerative colitis, and ankylosing spondylitis.

New research indicates that rheumatoid arthritis patients switching to biosimilars to adalimumab may see improved outcomes by sticking with their original treatment.

The etanercept biosimilar, YLB113 (Nepexto), maintained a favorable efficacy, safety, and immunogenicity profile through week 96.