Comparing efficacy and safety of P013, a proposed pertuzumab biosimilar, with the reference product in HER2-positive breast cancer patients: a randomized, phase III, equivalency clinical trial - PubMed
Source : https://pubmed.ncbi.nlm.nih.gov/36071409/
The proposed biosimilar P013 was equivalent to the reference product in terms of efficacy. The safety of both medications was also comparable.
Conclusions: The proposed biosimilar P013 was equivalent to the reference product in terms of efficacy. The safety of both medications was also comparable.
Biological patent thickets and delayed access to biosimilars, an American problem
Source : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9439849/
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....
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.
Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars
Source : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9420434/
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...
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.
Effectiveness and safety of a biosimilar-to-biosimilar switch of the TNF inhibitor etanercept in patients with chronic inflammatory rheumatic diseases
Source : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9424877/
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,...
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.
Model-Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development - PubMed
Source : https://pubmed.ncbi.nlm.nih.gov/36000498/
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)...
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...