Biosimilars

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.

The post-hoc analysis of a phase 3 clinical trial suggests SB15 has comparable clinical efficacy and safety to aflibercept in patients with nAMD.

Patients with UC and Crohn's disease showed higher drug levels and good acceptance when switching from intravitreal to subcutaneous infliximab.

Experts recommended the early use of anti-TNF therapy for patients with ulcerative colitis and Crohn disease, offering further input regarding the introduction, optimization, and maintenance of the treatment for patients with IBD.

Switching from biosimilar CT-P13 to SB2 is safe and effective, according to new research. The patients in the study had no significant changes in their psychometric assessments during the 12 month follow up.

Findings from the phase 1 study informed the clinical development program for GP40141 as a biosimilar treatment for ITP, demonstrating pharmacodynamic similarity to reference romiplostim.

SB16, a denosumab biosimilar, demonstrated pharmacokinetic and pharmacodynamic comparability with reference denosumab in a phase 1 trial in healthy male adults.

Samsung Bioepis gains FDA interchangeability designation for its ranibizumab (Lucentis) biosimilar, ranibizumab-nuna (Byooviz), in the treatment of wAMD, macular edema following RVO, and mCMV

Study finds the biosimilar ABP 654 and ustekinumab do not have clinical meaningful differences according to the step-wide totality-of-evidence approach and thus have similar psychochemical and biological properties.

A new study found that 83.3% of practitioners believe biosimilars are just as effective and safe as originator drugs. Yet, because of knowledge gaps related to biosimilars, patients fear disease flares caused by biosimilars, as well as the drug’s effectiveness.

Providers identified an increased administrative workload and inadequate biosimilar device training as pain points during a mandatory switch to a biosimilar.

The proposed denosumab biosimilar, SB16, demonstrated pharmacokinetic bioequivalence, as well as equivalent efficacy, safety, and immunogenicity,

Results of a recent systematic review demonstrated no difference in the immunogenicity rates and safety profiles in patients who switched to a biosimilar and those who continued to receive the reference product.

Feldman discusses the importance of self-education and open communication between patient and physician to help stay informed about relevant laws.

Feldman explains how healthcare legislation and regulation play a pivotal role in shaping patient care and costs.

Madelaine Feldman, MD, discusses the role pharmacy benefit managers play in delaying patient care.

Biosimilars to several recognized biologic rheumatoid arthritis treatments are now approved for use in the United States. Test your knowledge with this quiz.

Results demonstrated comparable safety, immunogenicity, and pharmacokinetics between adalimumab-afzb and the reference product.

The biosimilar month in review highlights an interview with leading experts, the latest data regarding switching between biologics and biosimilars, and the efficacy of infliximab biosimilars among patients with inflammatory conditions.

At week 16, no significant differences in response rates were observed regarding the adalimumab biologic and biosimilars.

The biosimilar was deemed comparable and tolerable in terms of safety between groups.

A trio of healthcare providers offer perspective on educating patients regarding biosimilar and interchangeability.

Phase 3 results show the non-inferior efficacy of biosimilar liraglutide to the originator in lowering HbA1C over 26 weeks of treatment.

Although most clinicians surveyed are unopposed to prescribing adalimumab biosimilars, hesitancies surrounding prescribing practices and an uncertainty of cost savings remains.

A review of Japan post-marketing data support the biosimilar in use for psoriasis, rheumatoid arthritis, Crohn's disease and ulcerative colitis.