Skip to main content
micro-community-banner
 
  • Saved

made a Post

The Role of PD Biomarkers in Biosimilar Development - To Get the Right Answer One Must First Ask the Right Question - PubMed

The potential for pharmacodynamic (PD) biomarkers to improve the efficiency of biosimilar product development and regulatory approval formed the premise for the virtual workshop Pharmacodynamic Biomarkers for Biosimilar Development and ..... see more

Source : https://pubmed.ncbi.nlm.nih.gov/36148870/


Conclusion/Relevance: We must carefully consider the core requirements and timelines inherent in biosimilar development and how they occur in parallel rather than in the series we see for originator products. In order to improve the efficiency of biosimilar development, we need to ask the right questions based on a full understanding of how...

  • Saved

made a Post

Rapid infusion of infliximab biosimilars and the incidence and severity of infusion-related reactions in patients with inflammatory bowel disease - PubMed

Rapid infusions of infliximab biosimilars were not associated with an increase in the incidence of infusion reactions compared with: rapid infusion of infliximab reference product, standard infusion of infliximab biosimilars, ..... see more

Source : https://pubmed.ncbi.nlm.nih.gov/36134561/


Conclusions: Rapid infusions of infliximab biosimilars were not associated with an increase in the incidence of infusion reactions compared with: rapid infusion of infliximab reference product, standard infusion of infliximab biosimilars, or standard infusion of infliximab reference product. This should reassure clinicians that rapid infusions...

  • Saved

made a Post

A randomized, double-blind, parallel control study to evaluate the biosimilarity of QL1209 with Perjeta® in healthy male subjects

Purpose: This is the first study to compare the pharmacokinetics, safety and, immunogenicity of QL1209, a biosimilar of Perjeta®.Methods: This study was a randomized, double-blind, parallel-controlled clinical trial evaluating the ..... see more

Source : https://www.frontiersin.org/articles/10.3389/fphar.2022.953641/full


Conclusion: The results of this comparative clinical pharmacology study demonstrated the PK similarity of QL1209 (420 mg: 14 ml) and Perjeta® (420 mg: 14 ml) and there was no significant difference in safety and immunogenicity between QL1209 and Perjeta® manufactured by Roche Pharma AG.

  • Saved

made a Post

Switching Among Biosimilars: A Review of Clinical Evidence

Biological medicines have improved patients' outcomes, but their high costs may limit access. Biosimilars, alternatives that have demonstrated high similarity in terms of quality, safety, and efficacy to an already ..... see more

Source : https://www.frontiersin.org/articles/10.3389/fphar.2022.917814/full


Conclusion: Switching studies seem difficult to perform and unnecessary with the body of evidence suggesting no real problems in practice coupled with stringent regulatory requirements. Monitoring the use of biosimilars in clinical practice could support clinical decision-making, rational use of biological medicines, and help to further...

  • Saved

made a Post


Conclusions: The proposed biosimilar P013 was equivalent to the reference product in terms of efficacy. The safety of both medications was also comparable.

  • Saved

made a Post

Biological patent thickets and delayed access to biosimilars, an American problem

Our study seeks to determine whether patent thickets covering biologic drugs are responsible for delayed biosimilar market entry. We compare patent assertions against the same biosimilar drugs across three countries. ..... see more

Source : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9439849/


Conclusion/Relevance: Patent thickets can allow brand name drug companies to delay biosimilar entry by relying on the high cost of challenging many duplicative patents instead of the quality of their underlying patents. Accordingly, we suggest several policy interventions that may thin these biologic patent thickets.

  • Saved

made a Post

Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars

After 18 years and the administration of billions of doses, there is little doubt about biosimilars' safety and efficacy. Yet, only 14 molecules in the EU and 9 in the ..... see more

Source : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9420434/


Conclusion: Only recently the regulatory agencies have begun to talk about this risk and shown their willingness to waive these studies. However, a clear change in the regulatory guidelines is required to change the mindset of all biosimilar stakeholders to bring a pivotal change in the availability of affordable biosimilars.

  • Saved

made a Post

Effectiveness and safety of a biosimilar-to-biosimilar switch of the TNF inhibitor etanercept in patients with chronic inflammatory rheumatic diseases

Uta Kiltz, Conceptualization, Formal analysis, Funding acquisition, Investigation, Methodology, Writing original draft, Styliani Tsiami, Formal analysis, Investigation, Writing review editing, Xenofon Baraliakos, Formal analysis, Methodology, Writing review editing, Ioana Andreica, ..... see more

Source : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9424877/


Conclusion: No relevant change in disease activity and physical function were observed in a non-medical bsDMARD-to-bsDMARD switch scenario. The retention rate after switches from originator ETN to two ETN bsDMARD was close to 90%. Multiple switches resulted in a high adherence rate without clinically important efficacy or safety signals.

  • Saved

made a Post

Model-Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development - PubMed

This study applied modeling and simulation (M&S) approaches to evaluate the sensitivity of pegfilgrastim pharmacokinetics (PKs) and pharmacodynamics (PDs) to changes in dose amount, and linear or nonlinear clearance (CL) ..... see more

Source : https://pubmed.ncbi.nlm.nih.gov/36000498/


Conclusion: Taken together, our analyses support that the approved pegfilgrastim dose of 6 mg is appropriate for detecting differences between a biosimilar and the reference products in pegfilgrastim PK and PD similarity studies. The described M&S approaches can be adopted to support dose selection for biosimilars with nonlinear PK and...

  • Saved

made a Post

Trends in Use of Granulocyte Colony-Stimulating Factor Following Introduction of Biosimilars Among Adults With Cancer and Commercial or Medicare Insurance From 2014 to 2019 - PubMed

1 Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville. 2 Center for Drug Evaluation and Safety, University of Florida, Gainesville. 3 College of Medicine, University ..... see more

Source : https://pubmed.ncbi.nlm.nih.gov/34812849/


Conclusions and Relevance: This cross-sectional study found that utilization of G-CSFs increased among patients with cancer with high FN risk in both a commercially and Medicare-insured population, but 14% to 17% of patients still did not receive preventive treatment.

  • Saved

made a Post

Comparison between filgrastim biosimilar and filgrastim original for the management of neutropenia after salvage chemotherapy for malignant lymphoma - International Journal of Hematology

In this study, the efficacy and safety of filgrastim biosimilar (F-BS) were retrospectively compared to those of filgrastim original in the treatment of malignant lymphoma with CHASE (± R) or DeVIC(± R) ..... see more

Source : https://link.springer.com/article/10.1007/s12185-022-03438-1


Relevance: In this study, the efficacy and safety of filgrastim biosimilar (F-BS) were retrospectively compared to those of filgrastim original in the treatment of malignant lymphoma with CHASE (± R) or DeVIC(± R) in 78 patients.

  • Saved

made a Post


Relevance: In this cross-sectional study, we describe and decompose changes in annual Medicare Part B spending for biologic drugs after biosimilar entry, focusing on the first 4 products to experience biosimilar competition: filgrastim, infliximab, epoetin alfa, and pegfilgrastim.

  • Saved

made a Post

The Nocebo Effect in a Non-Medical Switching Program from Originator to Biosimilar Infliximab in Inflammatory Bowel Disease - BioDrugs

Background Despite growing awareness of the nocebo effect, few studies have evaluated the nocebo effect using combined assessment of patient-reported outcome measures (PROMs), clinical indices, and objective biomarkers in inflammatory ..... see more

Source : https://link.springer.com/article/10.1007/s40259-022-00548-4


Conclusion: This study demonstrated a temporary yet discernible nocebo effect in the first 16 weeks following non-medical switching that was not sustained at week 32. Negative patient perceptions may be overcome by a patient-inclusive approach to non-medical switching in conjunction with close clinical follow-up and disease monitoring.

  • Saved

made a Post

Physician Payments from Pharmaceutical Companies Related to Cancer Drugs - PubMed

doi: 10.1093/oncolo/oyac160. Online ahead of print. 1 Health Outcomes Research Group, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA. 2 Delfi Diagnostics, Baltimore, MD, ..... see more

Source : https://pubmed.ncbi.nlm.nih.gov/35946837/


Conclusions: Although industry-sponsored education may also serve marketing purposes, the absence of association between industry payments and Medicare spending and the decline in payments subsequent to approval are consistent with claims that industry payments function to facilitate physician education.

  • Saved

made a Post

Cost-effectiveness of trastuzumab biosimilar combination therapy and drug wastage as first-line treatment for HER2-positive metastatic breast cancer

The rising cost of cancer drug therapy threatens the long-term sustainability of Taiwan National Health Insurance. Cost savings can be achieved through various strategies, e.g., using smaller vial sizes, sharing ..... see more

Source : https://www.thebreastonline.com/article/S0960-9776(22)00124-2/fulltext


Conclusion: The trastuzumab biosimilar combination regimen is cost-effective and offers significant drug cost savings in Taiwan.

  • Saved

made a Post

Understanding Biosimilar Insulins - Development, Manufacturing, and Clinical Trials - PubMed

Driven by price competition, the emergence of biosimilar insulins may help expand global access to current insulin analogues. To maximize the impact of the advantage for falling retail costs of ..... see more

Source : https://pubmed.ncbi.nlm.nih.gov/35818669/


Conclusions: Driven by price competition, the emergence of biosimilar insulins may help expand global access to current insulin analogues. To maximize the impact of the advantage for falling retail costs of biosimilar insulins compared with that of reference insulins, healthcare professionals and insulin users must gain further awareness and...

  • Saved

made a Post

Pegfilgrastim-Apgf (Nyvepria): Biosimilar USFDA Approval for the Treatment of Chemotherapy-induced Febrile Neutropenia and Current Updates on Clinical Trials

Pegfilgrastim-apgf (nyvepria) was currently approved by FDA for the treatment of febrile neutropenia associated with non-myeloid malignancies receiving myelosuppressive anticancer drugs. It was developed by Pfizer, USA. It is a ..... see more

Source : https://www.eurekaselect.com/article/122387


Relevance: Pegfilgrastim-apgf (nyvepria) was currently approved by FDA for the treatment of febrile neutropenia associated with non-myeloid malignancies receiving myelosuppressive anticancer drugs.

  • Saved

made a Post

Biosimilars Use In Medicine For Inflammatory Diseases

Biosimilars are biological agents that are highly analogous to their reference products currently approved and licensed by the U.S. Food and Drug Administration (FDA). Biosimilars possess no differences in their ..... see more

Source : https://www.ncbi.nlm.nih.gov/books/NBK574572/


Conclusion: Clinicians can expand their knowledge base and awareness of advances in biosimilars and their use in specialty practices from their respective specialty associations. Additional information can also be attained from the FDA website. The cost-saving potential of biosimilars should be taken into account and analyzed for the best...

  • Saved

made a Post

Cost-effectiveness of trastuzumab biosimilar combination therapy and drug wastage as first-line treatment for HER2-positive metastatic breast cancer - PubMed

doi: 10.1016/j.breast.2022.07.007. Online ahead of print. 1 Department of Obstetrics and Gynecology, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi, Taiwan. Electronic address: [email protected] 2 Department of Surgery, An-Nan Hospital, China ..... see more

Source : https://pubmed.ncbi.nlm.nih.gov/35870421/


Conclusion: The trastuzumab biosimilar combination regimen is cost-effective and offers significant drug cost savings in Taiwan.