Biosimilars

Biosimilars have the potential to create a more sustainable healthcare environment by offering substantial cost-savings and expanding patient access to life-saving therapies.
The advent of biologic drugs has had a significant impact on the management of patients with cancer. However, the high costs associated with these agents can hinder treatment access for many patients and place a significant burden on healthcare systems.
On September 20, 2021, the FDA announced the availability of its revised final guidance for industry on biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Febrile neutropenia (FN) is a serious side effect of many cancer treatments and can lead to severe infection and sepsis with potentially fatal consequences.
Due to the COVID-19 pandemic, the year 2020 has witnessed unprecedented changes in the practice of medicine and dissemination of treatment advances presented in scientific forums.
The totality of evidence generated from comparative systematic stepwise assessment of HD201 and trastuzumab reference in terms of analytical, pharmacodynamic, pharmacokinetic, and clinical similarity demonstrated the equivalence of HD201 to trastuzumab.
Population-based study results support the use of the neoadjuvant chemotherapy + pertuzumab + trastuzumab biosimilar SB3 treatment regimen in the real-world setting, with responses comparable with those achieved in clinical trials.
Simulation-modeling data demonstrate significant cost-savings by converting from reference pegfilgrastim with on-body injector to biosimilar pegfilgrastim-jmdb for prophylaxis of chemotherapy-induced neutropenia/febrile neutropenia in patients with diffuse large B-cell lymphoma (DLBCL).
The results of a phase 1 pharmacokinetic and safety equivalence study demonstrated equivalence between HD204 and both bevacizumab-EU and bevacizumab-US in healthy males.
Real-world national commercial administrative data showed that treatment adherence to infliximab biosimilar is high among patients who were infliximab-naïve, as well as those who had long exposure to infliximab.
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