Basaglar Is Not Associated With Lower Out-of-pocket Costs Than the Reference Product
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 Adoption
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.
Study: Liraglutide Biosimilar RD12014 Demonstrates Biosimilarity to Victoza
A phase 1 study in China found that pharmacokinetics, safety, and immunogenicity were similar between the liraglutide biosimilar RD12014 and the reference product (Victoza) in healthy male participants.
Biocon’s Biosimilar Insulin Demonstrates PK, PD Equivalence to Humulin
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 Interchangeability
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’ Preferences
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 Cancer
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 Options
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 Cancer
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 Cancer
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 Arthritis
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 Diseases
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 Development
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 Biosimilars
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 IBD
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.
Phase 1 Study Finds Similar PK Between Eculizumab Biosimilar, Soliris
A phase 1 study compared pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity between SB12, a proposed eculizumab biosimilar, and EU and US reference products (Soliris) in healthy adults.
Denosumab Biosimilar Demonstrates Noninferiority to Prolia in Postmenopausal Osteoporosis
Results from a phase 3 trial suggested similar efficacy and safety of the denosumab biosimilar candidate Arylia (AryoGen Pharmed) to the reference product (Prolia) in postmenopausal osteoporosis.
A Biosimilar Adoption Program Saved a US Nonprofit Health System $29.6M in 2 Years
The first 2 years of the program created $26.9 million in cost savings and “biosimilar adoption rates that greatly exceed the US national average."
Real-World Study Produces Positive Data on CT-P13 in North American Patients With IBD
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 Biosimilar
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 Study
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).
Study: Financial Viability of Biosimilars Depends on Originator Sales, Market Entry Order
A 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
An 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.
Health Services Utilization Following Mandatory Switching to Infliximab Biosimilar in British Columbia
A study assessing the impact of mandatory switching policies in British Columbia on patients with rheumatic conditions receiving infliximab therapy found that switching to a biosimilar did not result in increased health service use.
Prospective Study Finds Multiple Switches Between Infliximab Reference Product and Biosimilars is Safe and Effective in IBD
Authors of a new study demonstrated that multiple switches between infliximab biosimilars CT-P13 and SB2 and the reference product (Remicade) were safe and effective in patients with inflammatory bowel disease (IBD).
Over 90% of Patients Preferred Biosimilar Delivery With Prefilled Pen vs Syringe
A sub-study assessing the affects of using a prefilled pen vs a prefilled syringe found that the pen was easy for patients to use and was favored by over 90% of patients.
Real-world Study of Reference vs Biosimilar Ranibizumab for Treatment of Diabetic Macular Edema in India
A real-world analysis found similar safety and efficacy profiles between a biosimilar ranibizumab (Razumab) and the reference product (Lucentis, Accentrix) in Indian patients with diabetic macular edema.
Review of Totality of Evidence for Infliximab Biosimilar ABP 710
An article reviewed the totality of evidence leading to the approval of Amgen’s infliximab biosimilar ABP 710 (Avsola), which is currently approved in the US and Canada for all the indications of the originator (Remicade).
Case Study: Monitoring Needed for Patients With Both UC, AS Receiving Biosimilar Infliximab Treatment
A patient with ankylosing spondylitis (AS) and ulcerative colitis (UC) was diagnosed with polychondritis after taking an infliximab biosimilar, suggesting that patients with similar circumstances should be carefully monitored.
Trastuzumab-qyyp Maintains Stability and Potency Under Extended In-Use Conditions
Pfizer’s trastuzumab biosimilar (trastuzumab-qyyp; Trazimera) was stable and efficacious under conditions of extended use in patients with breast cancer, investigators concluded.
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