Biosimilars

A confirmatory efficacy and safety study demonstrated therapeutic equivalence, immunogenicity, pharmacokinetics, and safety of an aflibercept biosimilar.

An analysis of the Phoenix cohort provides insight into responder rates and treatment persistence with infliximab biosimilars among those with no previous exposure to biologics, a previous failure to respond to biologics, or those switching from reference infliximab.

Use of etanercept biosimilars was not associated with an increased likelihood of treatment discontinuation or disease activity among people with rheumatoid arthritis relative to continuing treatment with originator etanercept.

A program from the American Oncology Network shows promise to introducing cost-efficient biosimilar substitution opportunities to prescribers and payors.

An analysis from Taiwan suggest immunogenicity differences are limited between biosimilars approved by the FDA and their reference biologic products.

A switch from a biologic treatment to a biosimilar demonstrated comparable effects for both primary and co-primary outcomes in patients with rheumatoid arthritis.

The approval was based on evidence showing no clinically meaningful differences between natalizumab-sztn and the reference drug in terms of safety, purity, and potency.

Disease activity improved by week 16 in patients receiving CT-P13 and was maintained through the end of the treatment period.

Initial real-world experience with ranibizumab biosimilar agents revealed no unexpected adverse outcomes across 16 retina centers, with similar efficacy to reference ranibizumab.

Results from the CT-P42 3.1 Study indicate the therapeutic equivalence of the aflibercept biosimilar, CT-P42, to the reference product in eyes with DME.

Treatment with follitropin alfa resulted in a higher proportion of patients with good quality embryos and higher pregnancy rates when compared with the biosimilar group.

Comparable efficacy, including of BCVA, CST, and fluid status between SB15 and reference aflibercept, was maintained up to Week 56 in nAMD eyes.

Secondary endpoints, including safety, efficacy, immunogenicity, and pharmacokinetics, were highly similar between infliximab and biosimilar CMAB008.

Pharmacokinetic parameters and bioequivalence were comparable among patients receiving reference tocilizumab and its proposed biosimilar, HS628.

The empagliflozin reference drug and its biosimilar (CKD-370) demonstrated bioequivalence, and both treatments were well-tolerated among patients.

The biosimilar month in review highlights the July 1 launch of 7 adalimumab (Humira) biosimilars in the US and the cost-saving potential of increased biosimilar availability.

Stephen Pagnotta, executive director and Biosimilar commercial lead at Boehringer Ingelheim, discusses the significance of the US launch of biosimilar adalimumab-adbm and its interchangeable designation.

The estimated total savings was over €243 million for TNF, with over €166 million ascribed to reductions in treatment costs for rheumatic diseases.

Patients who completed the survey were significantly more likely to achieve 12-month persistence on adalimumab biosimilar SB5 when compared with non-respondents.

A single-center retrospective study is offering clinicians insight into the effects of biosimilar infliximab use on weight, height, and BMI trajectories in pediatric patients with inflammatory bowel disease.

The limited impact of past policy interventions to increase biosimilars uptake in Belgium suggests a need for individualized, proactive measures.

Results showed even at a 55% discount, the biosimilar adalimumab-atto still costs more than double the launch price of reference adalimumab.

The main pharmacokinetic parameters were comparable between the tocilizumab reference and the biosimilar cohorts.

The use of infliximab, adalimumab and etanercept following biosimilar entry increased by 88.9%, 22.4%, and 14.6%, respectively.

The biosimilar month in review highlights ranibizumab biosimilars for the treatment of nAMD, Optum Rx’s decision to recognize subcutaneous adalimumab-adbm as a preferred brand, and the cost-saving benefits of biosimilars for patients.

The citrate-free high-concentration formulation and citrate-containing low-concentration of biosimilar adalimumab-bwwd are now available to patients living in the US.

Significant improvements seen in hematologic parameters, visceral volumes, and plasma biomarkers in patients with Gaucher disease, suggesting its potential as an alternative therapy, particularly for those who cannot access enzyme replacement therapy.

Optum Rx announced it will place the biosimilar adalimumab-adbm (Cyltezo) injection on its commercial formulary as a preferred brand.

A systematic review and meta-analysis found no significant differences in visual and anatomical outcomes between ranibizumab biosimilars and reference ranibizumab in eyes with neovascular AMD.

The rituximab biosimilar rixathon was linked to the the lowest average annual cost per patient across 6 indications among all biosimilars.