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).
Investigators Weigh Differences in Biosimilar Quality Reporting
Consistency of reporting quality attributes for biosimilars may differ, complicating the job of getting a full picture of biosimilarity.
Infliximab Biosimilar Switching Study Yields Evidence of Safety, Efficacy
A need for clinical evidence on the efficacy and safety of infliximab switching led the authors to pursue this investigation.
Study: Machine Learning Could Optimize Biosimilar Therapy
Authors of a new study conclude that artificial intelligence could improve the selection of biosimilars for therapy.
Reviewers Consider "Totality of Evidence" for Mvasi
Providers should feel confident using Mvasi, a bevacizumab biosimilar, for all indications of the reference product (Avastin), reviewers stated.
Policy Review Cites Need for Regulatory Clampdown on Pay-for-Delay Tactics
An international group of physicians, surgeons, lawyers, scientists, and pharmacists weighs in on biosimilar policy differences and deficiencies in the United States, Europe, and Japan.
WHO Survey Identifies Global Regulatory Challenges for Biosimilars
A survey of 20 countries highlights the remaining regulatory challenges facing biosimilar adoption.
US Rheumatologists Understand and Accept Biosimilars, but Some Hesitation Remains
Study: Specialty Drug Spending Net of Rebates Soars for Private Insurance, Medicare Part D
This study of specialty drug spending looks beyond rebates to evaluate growth in spending from 2010 to 2017.
Europeans Devise Checklist for Promoting Biosimilar Use
European investigators have derived a set of core principals for developing higher utilization of biosimilars.
CT-P10 and Reference Rituximab Evaluated in Primary Sjögren Syndrome
Investigators note similar efficacy and safety profiles in real-life study of reference and biosimilar forms of rituximab.
Potential Cost Savings From Improving Biosimilar Availability in Slovakia
Biosimilars could improve health system sustainability in Slovakia; however, of the 54 biosimilars approved by the European Medicines Agency as of August 2019, fewer than half are available in Slovakia
Report: Germany Has Not Fully Realized Its Biosimilar Potential
Germany could eke out more gains from biosimilars on top of its already impressive savings, investigators write.
UK Regulators Contend Biosimilar Efficacy Trials Are Redundant
Much of the groundwork for establishing equivalence is established in the pharmacokinetic evaluation. Further studies add less and less to the body of evidence for biosimilar approval, UK regulators write.
Study Suggests Biosimilar Suffixes Influence Patient Willingness to Switch
The random jumble of letters that the FDA attaches to new biologics and biosimilars plays a big role in patient acceptance of these drugs, investigators report.