Biosimilars
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].
Biosimilars applications under review by EMA – April 2016
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
