Biosimilars/Research
Updates for European Pharmacopoeia monographs for biotherapeutic products
The European Pharmacopoeia produces monographs for biotherapeutic products that are publicly available and considered the standard for defining the quality of these medicines. A recent study published in GaBI Journal [1] examines whether the challenges posed by complex products such as the introduction of biosimilars, have been met by new elements that have been added to the monographs.
Recommendations for improving biosimilar regulations in Latin America
The biosimilar regulatory scenario is very diverse and varies widely in the large group of Latin American countries. Authors Teran et al. presented some recommendations for making biosimilar regulations in Latin America more homogeneous and comprehensive [1].
Successful trials for Sandoz and Lannett biosimilars
On 19 September 2022, Sandoz announced positive results following its ROSALIA I/III clinical trial study for its proposed biosimilar denosumab. This follows the August announcement that Lannett Company successfully completed subject dosing in the clinical trial of its biosimilar insulin glargine.
Recommendations to address challenges to biosimilars in Latin America
After reviewing the regulatory landscape for biosimilars [1] and access to biosimilars for cancer treatments in Latin America [2], authors Teran et al. advised several recommendations to address challenges related to poor access to biosimilars in Latin America healthcare systems.
Totality of evidence for biosimilar pegfilgrastim Ziextenzo
Agarwala et al. have recently published a review on the totality of evidence (ToE) for the biosimilar pegfilgrastim Ziextenzo® (LA-EP2006) matching the European Union- (EU) and US-reference biological pegfilgrastim Neulasta® (marketed by Amgen) [1].
What does the designation of interchangeability for biosimilars in the US mean?
Biologicals have significantly improved patients’ quality of life, yet, access to these critical medicines are constrained due to cost and this is being exacerbated by the misperceptions around biosimilars. In particular, imprecise terminology has been applied to biosimilars, leading to the implication that biologicals designated as interchangeable by the US Food and Drug Administration (FDA) are better biosimilars. The US is the only jurisdiction in the world with this additional designation from the regulator as an option for biosimilar sponsors to consider [1].
Access to biosimilars for cancer treatments in Latin America
In many Latin America countries, patient access to biosimilars for cancer treatment remains restricted. In particular for patients with breast cancer and colorectal cancer, biosimilars can be a step further to increasing access to care [1].
Biosimilar regulations perspective in Latin America to improve cancer treatment access
To address the issue of regulatory process of biosimilars, including intended copies*, the Americas Health Foundation (AHF) conducted a literature review and convened a panel with eight experts in biological cancer therapies and health economics to address the most salient issues concerning the regulation of biosimilars in Latin America [1].
Pegfilgrastim biosimilar Udenyca demonstrated similar immunogenicity to Neulasta
The pegfilgrastim biosimilar Udenyca (pegfilgrastim-cbqv) is a pegylated, long-acting form of filgrastim (granulocyte colony-stimulating factor [G-CSF]). It is approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a biosimilar of the originator pegfilgrastim (Neulasta) for febrile neutropenia in patients receiving myelosuppressive chemotherapy [1, 2].
Therapeutic drug monitoring with infliximab improves disease control
The latest study from the Norwegian Drug Monitoring (NORDRUM) trial [1] shows that proactive therapeutic drug monitoring (TDM) for patients receiving maintenance infliximab therapy improves disease control, compared to treatment without TDM.
