Pooled Analysis of 3 Trials Finds Biosimilar Pegfilgrastim-cbqv Has Similar Immunogenicity to Reference Product
The authors noted that “all biologic therapeutics can be immunogenic or elicit an immune response,” and that an assessment of immunogenicity is part of the totality of evidence required for regulatory approval of biosimilars.
Adalimumab Biosimilar SB5 Effective in Behçet’s Syndrome-Related Uveitis and IBD, Studies Find
Two new studies have investigated the adalimumab biosimilar SB5 (Imraldi; Samsung Bioepis) in inflammatory bowel disease (IBD; Crohn’s disease and ulcerative colitis) and non-anterior uveitis associated with Behcet's syndrome (BS).
Real-world Study Sees Adoption of Mvasi by US Oncologists for Metastatic CRC
Records show the biosimilar for bevacizumab was used to treat both new patients and those already receiving care with the reference product.
Pharmacokinetic and Pharmacodynamic Equivalence of Biocon’s Proposed Biosimilar Insulin-R to Humulin-R
Insulin costs have increased dramatically in recent years, and the study authors note that high costs for many patients result in nonadherence or insulin rationing, leading to diabetic complications and even death.
Study: Epoetin Alfa Biosimilar Candidate Equivalent to Epogen
A comparative study of PanGen Biotech’s epoetin alfa biosimilar candidate PDA10 and the reference product, Retacrit, demonstrated comparable efficacy and safety.
Bevacizumab Biosimilar Candidate Demonstrates High Similarity to Avastin in NSCLC
Patients with stage IV nonsquamous non–small cell lung cancer (NSCLC) demonstrated equivalent outcomes when treated with MYL-1402O or Avastin.
Sandoz Reviews Insulin Access, Cost, and Biosimilar Potential
In a review, Sandoz researchers discuss lingering barriers that prevent insulin prices from falling to more affordable levels.
Machine Learning Clarifies Stress-Based Degradation of Biosimilars
A study of trastuzumab biosimilars and the reference product (Herceptin) under control and stress conditions elucidated the value of machine learning.
High Cost, Low Access Still Plague Insulin Market at 100-Year Anniversary
Authors of a review discuss barriers to insulin access and potential solutions as the 100-year anniversary of the drug's first use for diabetes gets closer.
Investigators Review Marketed Adalimumab Biosimilars for Switching Differences
Investigators in Spain said they found no significant differences in outcomes for patients who switched from adalimumab originator to 1 of multiple adalimumab biosimilars.
Study: Zarxio More Costly Than Neupogen in Outpatient Hospital Setting
According to a multiyear, retrospective study, filgrastim biosimilar Zarxio cost $20.50 more on average per administration than reference Neupogen in the hospital outpatient setting.
Meta-analysis of Sandoz Pegfilgrastim PK/PD Studies Supports Biosimilarity
A meta-analysis of pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of Sandoz pegfilgrastim biosimilar confirms biosimilarity.
Study: Biosimilar rhGH Well Tolerated and Effective in Turner Syndrome
A multicenter study of recombinant human growth hormone (rhGH) in children with Turner syndrome demonstrated safety and efficacy comparable to the reference product.
Dutch Study Confirms Response, Survival for Rituximab Biosimilars in DLBCL
A retrospective study of rituximab biosimilars Truxima and Riximyo demonstrated comparable response and survival for patients with diffuse large B-cell lymphoma (DLBCL).
Average Net Price for Insulin Glargine Declined After Basaglar Won FDA Approval
The average net price of all insulin glargine products decreased between 2015 and 2020 following the steady price increase seen for Lantus from 2010 to 2014.
Study Supports Switch From Remicade to SB2 in IBD
Real-world study in Italy finds most patients with inflammatory bowel disease (IBD) maintain clinical and biochemical response after switching from infliximab reference product to SB2.
Authors Propose Elimination of "Double Standard" for Biosimilars
Authors of an opinion piece suggest that a "reliance" approach to biosimilar approval could lead to global standards for acceptance that cut down on wasted review time and obsolete clinical investigation.
Trastuzumab Model Measures Expanded Access With Ogivri Biosimilar
Investigators determine that converting at least 2 patients with metastatic breast cancer to a trastuzumab biosimilar could generate savings enough to treat a third patient.
Analysis: G-CSF Biosimilars Could Reduce Costs While Improving FN-Related Outcomes
Wider use of granulocyte colony-stimulating factor (G-CSF) biosimilars is recommended for patients at risk of febrile neutropenia (FN).
Biosimilar Switching Study Demonstrates Value of Patient Support, Education
Investigators in British Columbia surveyed patients for their impressions of biosimilars before and after mandatory switching.
Study: Grastofil Equivalence Confirmed in ASCT Setting
A Canada study of the filgrastim biosimilar Grastofil demonstrated equivalence to Neupogen in candidates for autologous stem cell transplantation (ASCT), an extrapolated use.
Inflectra Stands Out in Meta-analysis of Agents for Crohn Disease
Investigators ranked biologics and Janus kinase 1 inhibitors based on past findings.
Investigators Measure Pegfilgrastim Biosimilar Savings Potential
The savings from pegfilgrastim biosimilars rapidly add up, according to a study simulation that accounted for hospital costs associated with the on-body injector.
Indian Biosimilar Standards: A Work in Progress
India has tightened up guidelines for biosimilar development in a quest to achieve standards equivalent to those in Europe and the United States.
Investigators Question Use of Animal Toxicology Studies for Biosimilar Development
Animal toxicology studies contribute little to demonstrations of biosimilarity and yet these studies frequently must be done to satisfy international regulatory requirements, investigators conclude.
AAM Seeks Changes to CMS Policy on Generics, Biosimilars
Unsustainably low prices for generics are preventing some manufacturers from producing them, while biosimilars are blocked by policies that favor originator drugs, the Association for Accessible Medicines (AAM) argues.
Study: Trastuzumab Biosimilar IV Offers Better Value Than Reference SC
In a review of trastuzumab treatment options, reviewers concluded subcutaneous (SC) vs intravenous (IV) options may be more costly and sometimes less practical.
Study: Increasing Biosimilar Use in RA Requires Greater Disease Management Knowledge
Biosimilar availability will expand treatment of rheumatoid arthritis (RA) to more patients and earlier disease settings, so it's important to understand the potential complications.
Long-term Observational Study Supports Switch From Infliximab to SB2 in IBD
A long-term observational study suggests a non-medical switch from infliximab to SB2 is “a feasible option” for patients with inflammatory bowel diseases (IBD).
Study: Bevacizumab Biosimilar Finds Acceptance in First-Line Treatment of mCRC
Investigators noted comparable use of bevacizumab biosimilar and reference products among patients treated for metastatic colorectal cancer (mCRC).
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