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Effectiveness of ESAs in treating anaemia in kidney disease and cancer patients

Erythropoiesis-stimulating agents (ESAs) are biological analogues of human erythropoietin used for the treatment of anaemia associated with chronic kidney disease (CKD) and chemotherapy treatment in cancer patients [1]. ESA biosimilars have been available on the Italian market since 2007. However, only limited post-marketing data exist on the comparative effectiveness of biosimilar and originator ESAs in routine care.

Monoclonal antibodies and the challenge of substitution

Healthcare payers are eagerly awaiting the arrival of biosimilar competition in the innovative monoclonal antibody sector in order to drive down drug prices and increase patients’ access to these medicines. As the first to introduce scientific and regulatory requirements for the approval of biosimilars in 2004, the European Union (EU) has emerged as a testing ground for biosimilars. In view of the lack of stance of EU governments and national institutions on substitution for biosimilars, hospitals and healthcare structures logically took up this major issue.

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.

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.

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].

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].

Improving uptake of biosimilars in Spain

Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain, investigated how efforts to improve the uptake of biosimilars in the country have been working.

Biosimilars: the clinical perspective

How biosimilars can be viewed from a clinical perspective was discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.

A multidisciplinary perspective on biosimilars

A biosimilar is an officially regulated and approved copy of an originator biological therapy. Authors Khraishi et al. aimed to provide a comprehensive review of the biosimilar development process and multidisciplinary guidance on their potential therapeutic utility in clinical practice [1]. They discussed clinical developments in the introduction of biosimilars across the expert disciplines of gastroenterology, nephrology, oncology and rheumatology, and from a payer perspective. They highlight a common need for ongoing pharmacovigilance, robust head-to-head clinical studies, and real-world data to establish the long-term risk-benefit profile of biosimilars.

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