Preclinical Study Shows Comparability Between Omalizumab Biosimilar, Xolair
February 11th 2023The 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 nAMD
January 28th 2023A 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 France
December 31st 2022A 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 Product
December 24th 2022The “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 Adoption
December 17th 2022Despite 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 Humulin
December 3rd 2022The 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 Interchangeability
November 26th 2022The 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).
A Summary of the VOLTAIRE-RA Trial for Physicians, Patients Considering RA Treatment Options
November 5th 2022Authors 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 Cancer
October 29th 2022Authors 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 Cancer
October 15th 2022A 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 Arthritis
October 8th 2022A 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 Diseases
September 24th 2022In 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 Development
September 3rd 2022In 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 Biosimilars
August 27th 2022A 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 IBD
August 22nd 2022Researchers 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 IBD
July 16th 2022A 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 Biosimilar
July 9th 2022A 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 Study
July 2nd 2022In 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).
Study: Financial Viability of Biosimilars Depends on Originator Sales, Market Entry Order
June 18th 2022A financial evaluation study proposed a framework for choosing which biosimilar candidates companies should develop, a process that requires a detailed and careful analysis to ensure that the candidate will be successful in global biopharmaceutical markets.
Similar Effectiveness, Safety of Biosimilar CT-P6 vs Reference Trastuzumab in Retrospective Study
June 13th 2022An analysis of retrospective data demonstrated comparable safety and efficacy profiles between CT-P6, a trastuzumab biosimilar, and Herceptin (reference trastuzumab) combined with chemotherapy and pertuzumab.