Biosimilars
Pharmacokinetic behaviour of a trastuzumab biocomparables
Biosimilars represent a viable alternative for the treatment of chronic and degenerative diseases of many patients worldwide who cannot afford the costs of biotherapies based on originator products. Trastuzumab is a humanized monoclonal antibody, which is used for the treatment of HER2-positive breast cancer. In the review paper of Miranda-Hernández et al. [1], the authors described the development of a trastuzumab biocomparable by Mexico-based Probiomed. This biocomparable, according to the authors, was developed in compliance with international guidelines and the characterization of Critical Quality Attributes (CQAs), as well as the pharmacokinetic parameters evaluated in healthy volunteers, demonstrated comparability with the reference product.
Switching between different ESAs
Switching between reference biologicals and biosimilars can be a contentious issue. A study from Italy, however, has found that this phenomenon is not limited to reference products and their biosimilars, but also often occurs between originator biologicals and other originator biologicals within the same category [1].
Positive phase III results for omalizumab copy biological
US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 16 May 2016 that its partner, MabTech had successfully completed a combined phase II and III clinical trial in China for STI-004, a copy biological for omalizumab (Xolair). STI 004 met its primary endpoint in a multicentre, randomized, double-blind, placebo-controlled, clinical study.
Uptake of biosimilars increasing in Spain
Use of biosimilars in Madrid, Spain, has increased after approaches were introduced to try and improve uptake of biosimilars in the country, according to Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain [1].
Clinical and regulatory issues for biosimilars
As the first biosimilars are being approved in the US, there are a number of clinical and regulatory issues that must be considered for the safe and appropriate utilization of these products within the health system [1]. Biosimilars provide the opportunity to lower cost and improve access to important biological treatments. However, their success will depend largely on their acceptance by clinicians, payers and patients.
Samsung Bioepis to launch infliximab biosimilar in South Korea
Samsung Bioepis has completed the regulatory process to enable the launch of its second biosimilar Renflexis (infliximab) in South Korea.
Japan proving to be a favourable market for biosimilars
Uptake of biosimilars in Japan is on a par with generics use for some products, making Japan a lucrative market for biosimilars makers.
Approaches to increase uptake of biosimilars in Spain
Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe approaches that have been introduced in Spain to try and improve uptake of biosimilars in the country [1].
Benepali wins Danish tender for etanercept
Denmark’s drug procurement agency Amgros has chosen the etanercept biosimilar Benepali, made by Samsung Bioepis, as the priority drug for treating rheumatoid arthritis rather than the originator biological (Amgen’s Enbrel).
A strategic approach to increase uptake of biosimilars in Spain
Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, describe the strategic approach that has been introduced in Spain to try and improve uptake of biosimilars in the country [1].
