Real-world Studies Show Comparable Outcomes, Higher Discontinuation Rates Between Originators, Biosimilars in RAMarch 25th 2023
A review of real-world studies assessing patient-reported outcome measures of patients with rheumatoid arthritis (RA) found that although clinical outcomes were similar, patients taking a biosimilar were found to have higher discontinuation rates, possibly as a result of the nocebo effect.
Retrospective Study Supports Safety of Anti-TNF Biosimilars During PregnancyMarch 18th 2023
More and more women are becoming pregnant while on anti–tumor necrosis factor (TNF) biosimilars used to treat inflammatory disorders. However, there is “little data” on the safety and effectiveness of biosimilars in pregnancy, according to authors of a recent retrospective study.
Review: 15 Years of Real-world Data Demonstrates Safety of Epoetin Alfa Biosimilar HX575March 4th 2023
Authors of a review of safety results across indications and study designs on the epoetin alfa biosimilar HX575 concluded that HX575 “has repeatedly demonstrated long-term safety” in all approved indications in both clinical trials and real-world studies.
Sintilimab Plus Bevacizumab Biosimilar Therapy Associated With Better Outcomes, Higher Costs Than LenvatinibFebruary 25th 2023
According to the authors of a cost-effectiveness analysis of treatments for hepatocellular carcinoma (HCC) in China, sintilimab plus a bevacizumab biosimilar could improve quality of life for patients, but at a higher cost than lenvatinib.
Study: Higher Adherence Rates Among Users of the Remicade vs Infliximab BiosimilarsFebruary 18th 2023
An analysis of US claims data found that prevalent (as of 2017) users of the infliximab reference product (Remicade) had the highest adherence rates compared to naïve originator users, prevalent biosimilar users, and naïve biosimilar users over 18 months of follow-up.
Preclinical Study Shows Comparability Between Omalizumab Biosimilar, XolairFebruary 11th 2023
The proposed omalizumab biosimilar KA (Shanghai Taiyin Biotechnology) demonstrated similar analytical characteristics, in vitro biological activity, and pharmacology and toxicology in animals compared with the originator (Xolair), according to investigators.
Phase 3 Trial Suggests Equivalence Between Biosimilar CKD-701 and Reference Ranibizumab in nAMDJanuary 28th 2023
A phase 3 analysis found that CKD-701, a ranibizumab biosimilar candidate developed by CKD Limited, has comparable clinical efficacy and safety with the reference product (Lucentis) in patients with neovascular age-related macular degeneration (nAMD).
TNF Inhibitor Biosimilar Use in FranceDecember 31st 2022
A study assessing the use of tumor necrosis factor (TNF) alpha inhibitor biosimilars in France found that the biosimilar penetration rate was higher for infliximab compared to etanercept and adalimumab. The authors said they aimed to understand the key drivers for biosimilar use to improve biosimilar uptake in France.
Basaglar Is Not Associated With Lower Out-of-pocket Costs Than the Reference ProductDecember 24th 2022
The “biosimilar-like” insulin glargine Basaglar was not less expensive for patients than the reference product, Lantus, concluded the authors of a retrospective analysis of commercial pharmacy claims and pharmacy co-payment offsets.
Prescribers’ Perspectives on Strategies for Increasing Biosimilar AdoptionDecember 17th 2022
Despite recent steps taken by the FDA to streamline approvals and increase availability for biosimilars, biosimilar adoption has been slow and primarily driven by payers in the United States, signaling that more needs to be done to encourage adoption, according to experts at a virtual workshop hosted by the FDA and the University of Maryland.
Biocon’s Biosimilar Insulin Demonstrates PK, PD Equivalence to HumulinDecember 3rd 2022
The third in a series of clinical studies evaluating pharmacokinetics (PK) and pharmacodynamics (PD) of Biocon’s recombinant human insulins compared to their reference products, found PK and PD equivalence between the biosimilar insulin-70/30 and Humulin-70/30.
VOLTAIRE-X Findings in Patients With Chronic Plaque Psoriasis Supported InterchangeabilityNovember 26th 2022
The VOLTAIRE-X randomized controlled trial determined the adalimumab biosimilar BI 695501 (adalimumab-adbm, Cyltezo; Boehringer Ingelheim) met the FDA’s criteria to be designated as interchangeable with the reference product (Humira).
Administration for Pegfilgrastim Biosimilars Should Minimize Clinic Visits, Consider Patients’ PreferencesNovember 19th 2022
A review explored the 3 main administration options for pegfilgrastim biosimilars, finding that providers should consider the ease and frequency to which patients will need to travel to a clinic for administration as well as their preferences when choosing a mode of administration.
Meta-analysis Confirms Biosimilarity Between Bevacizumab Biosimilars, Avastin in NSCLC, Colorectal CancerNovember 12th 2022
The efficacy and safety of bevacizumab biosimilars in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (CRC) is comparable with the reference product (Avastin) and each other, according to a meta-analysis.
A Summary of the VOLTAIRE-RA Trial for Physicians, Patients Considering RA Treatment OptionsNovember 5th 2022
Authors of a plain-language summary of the VOLTAIRE-RA study examined how to help patients with rheumatoid arthritis (RA), their families, patient advocates, and health care professionals learn about potential new treatment options as the United States prepares for the introduction of adalimumab biosimilars.
Overview of Trastuzumab Biosimilars in HER2-Positive Breast CancerOctober 29th 2022
Authors of a systematic review summarized the results of 21 published studies on the efficacy, safety, and cost-benefit ratio of trastuzumab biosimilars in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Trastuzumab Biosimilar Found Safe, Effective in Pretreated HER2-Positive Breast CancerOctober 15th 2022
A study from the Republic of Korea confirmed the safety and efficacy of Herzuma (CT-P16) in patients with heavily pretreated human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
Rituximab Biosimilar Plus Methotrexate Improves Outcomes in Rheumatoid ArthritisOctober 8th 2022
A placebo-controlled clinical trial found that rituximab biosimilar HLX01 in combination with methotrexate was successful at improving the clinical outcomes of patients with moderate-to-severe rheumatoid arthritis.
A Guide to Biosimilars for Retinal DiseasesSeptember 24th 2022
In a review article discussing the role of biosimilars in neovascular retinal diseases, the authors concluded that biologics have significantly improved patient outcomes, noting that vascular endothelial growth factor inhibitors are now considered first-line treatments.
Upcoming WHO Guideline Changes May Reduce Data Requirements for Biosimilar DevelopmentSeptember 3rd 2022
In advance of the World Health Organization (WHO) updating its guidelines for biosimilar development, a review article concluded that comparative clinical efficacy and safety studies may not be helpful for the evaluation of biosimilars.
The Future of Anti-inflammatory BiosimilarsAugust 27th 2022
A review article chronicled the emergence of anti-inflammatory biosimilars in the United States and European Union and made predictions for where the market is headed, especially as etanercept and adalimumab biosimilars gain more prominence.
Biosimilar Infliximab Deemed Safe, Effective in Pediatric Patients With IBDAugust 22nd 2022
Researchers found that an infliximab biosimilar was as safe and effective as the reference product (Remicade) in pediatric patients with inflammatory bowel disease. However, more studies on adalimumab biosimilars in pediatric patients are needed.
Real-World Study Produces Positive Data on CT-P13 in North American Patients With IBDJuly 16th 2022
A real-world study on Pfizer and Celltrion Healthcare’s infliximab biosimilar (infliximab-dyyb, Inflectra; CT-P13) demonstrated positive clinical and patient-reported outcomes in patients with inflammatory bowel disease (IBD) in the United States and Canada.
Survey: Most Patients Received Inadequate Information About Switching to a Trastuzumab BiosimilarJuly 9th 2022
A survey study found that many patients with breast cancer reported receiving inadequate information regarding switching from Herceptin to a trastuzumab biosimilar, with some patients reporting that they were never told a switch occurred or what a biosimilar was.
Henlius’ Pertuzumab Biosimilar Shows Similar PK Profile to Reference Product in First Human StudyJuly 2nd 2022
In the first human study of Shanghai Henlius Biotech's pertuzumab biosimilar candidate (HLX11), investigators found similar pharmacokinetic (PK), safety, and immunogenicity profiles between the biosimilar and the reference product (Perjeta).