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.
Investigators Eye Gaps in Biosimilar Assessment Reports
Health technology tssessments play an important role in building confidence for use of biosimilars, yet very few meet criteria for thoroughness.
Updated "User's Guide" Published for Anti-TNFs in IBD
Two decades of using anti–tumor necrosis factor (TNF) drugs in inflammatory bowel disease (IBD) have answered some questions and left others unanswered.
Celltrion Refutes Critique of CT-P13 Equivalence
Celltrion finds fault with a critique of equivalence margins used to approve its infliximab biosimilar.
Anti-TNF Biologics Outperform in Crohn Disease
A real-world study on inflammatory bowel disease employing originator and biosimilar biologics suggests anti–tumor necrosis factor (TNF) therapy may be more effective for Crohn disease than for ulcerative colitis.
Study: Slow Start for Infliximab Biosimilars
Investigators speculate on why infliximab biosimilars don’t have a larger market share by now.
In Search of Better Algorithms for Treatment of Crohn Disease
Wide variation in treatment patterns for Crohn disease is attributable to failures to translate evidence uniformly and cost barriers. Authors of a new report have formulated algorithms to help reduce heterogeneity in treatment of patients.
Use of Infliximab Biosimilar in Medicare Population Is Low but Growing
Slow growth of use of biosimilar infliximab in a Medicare fee-for-service population suggests lingering hesitancy on the part of gastroenterologists and patients, particularly when it comes to extrapolation to off-label uses, according to a new study.
Study Suggests Majority of Rituximab Use Is Off Label
Rituximab was originally approved in the United States in 1997 for treatment of non-Hodgkin lymphoma and has multiple additional approvals for orphan and nonorphan indications. But a recent study found off-label uses now account for more than half of patients receiving rituximab.
Orphan Drug Exclusivity Keeps Biosimilars Off the Market, Study Says
Investigators found that manufacturers appear to be exploiting orphan drug exclusivities to extend market dominance and keep generics and biosimilars at bay.
Could New Therapies for Macular Degeneration Leave Anti-VEGF Biosimilars Behind?
The currently available anti–vascular endothelial growth factor (anti-VEGF) therapies for wet age-related macular degeneration (AMD) are costly, but biosimilars in clinical development may ease this problem.
Researchers Take Issue With Methods Used to Arrive at Recommendation Against IBD Nonmedical Switching
A joint position statement on biosimilars for the treatment of inflammatory bowel disease (IBD) sparked backlash and criticism over the recommendation against nonmedical switching from reference infliximab to a biosimilar.
Criticism Dogs Launch of Trade Agreement
The United States–Mexico–Canada Agreement came to a rocky impasse over drug exclusivity protections, and July 1 is the day this agreement takes effect.
Fresenius Kabi Pegfilgrastim Shows Matching Safety, Immunogenicity
Fresenius Kabi’s pegfilgrastim biosimilar candidate has demonstrated a similar safety and immunogenicity profile to the reference product (Neulasta).
Investigators Propose Different Measures for Biosimilar Equivalence
Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence for biosimilars.
Report: Biosimilars Are Underutilized in IBD
In inflammatory bowel diseases (IBD), biosimilars have been available for roughly 5 years, but more evidence may be necessary to persuade medical community to increase usage, according to a study.
Why Pharmacovigilance Is Important for Biosimilars
So many factors have the potential to affect the quality and performance of biosimilars that clinicians must be aware of the need for constant pharmacovigilance.
Investigators Recommend a More Systematic Effort to Get Biosimilars Adopted
A gentle, persuasive effort to get patients and physicians to adopt biosimilars is likely to work better than a heavy-handed approach, say Canadian investigators, who recommend more study of how mindsets and prescribing practices are changed.
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