Biosimilars
Australia’s DoH seeks feedback on biosimilars awareness project
Australia’s Department of Health (DoH) wants to improve awareness and confidence in biosimilars in the community and among healthcare professionals, including pharmacists and prescribers. To do this the DoH has developed an implementation framework, for which it is seeking feedback.
Pharmacovigilance compliance for biocomparables in Mexico
Filgrastim is widely used in Mexico, as in other countries. Its patent has expired and hence several non-originator biologicals have appeared. Following WHO guidelines, the General Health Law of Mexico was modified in 2009 to provide a solid regulatory environment for biosimilars (or biocomparables as they are called in Mexico) [1].
Positive phase I results for pegfilgrastim biosimilar
US-based biosimilars developer Coherus BioSciences (Coherus) announced on 1 October 2015 that results from a phase I study of its pegfilgrastim biosimilar (CHS‑1701) had met its primary endpoint.
Baxalta and Momenta start phase III trial for adalimumab biosimilar
Baxalta – a spinoff company from Baxter International – and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 5 October 2015 that they had started a phase III clinical trial for their adalimumab biosimilar (M923) in patients with chronic plaque psoriasis.
European paediatricians advocate biosimilar trials in children with IBD
Paediatricians from Europe are concerned about the extrapolation of the limited amount of available clinical data from adults with rheumatologic diseases to children with inflammatory bowel disease (IBD) [1].
Answers to questions about anti-TNF biosimilars
While the potential pharmacoeconomic benefits of cost-effective biosimilars seem clear, several issues have been raised regarding, for example, the definition of biosimilarity and the validity of indication extrapolation, as well as the ‘switchability’ and relative immunogenicity of biosimilars and their reference drugs. In a review by Isaacs and co-authors, these questions with reference to CT-P13 (Remsima, Inflectra), a biosimilar of the anti-tumour necrosis factor (TNF) monoclonal antibody infliximab (Remicade) were discussed [1].
FDA accepts application for etanercept biosimilar
Sandoz, the generics division of Novartis, announced on 2 October 2015 that the US Food and Drug Administration (FDA) had accepted its application for its etanercept biosimilar (GP2015).
Another infliximab switching trial started
In The Netherlands another study has been initiated into the effects of switching patients from originator infliximab to biosimilar infliximab.
Biosimilar epoetin-α as effective as originator in anaemia treatment
A study by researchers in Italy has concluded that biosimilar epoetin‑α appears to be comparable to originator epoetin‑α plus liposomal iron (Sideral), vitamin B12 and folates in terms of efficacy and safety for the treatment of refractory anaemia [1].
Biosimilar etanercept safe and effective
In a study funded by Samsung Bioepis (a Biogen and Samsung joint venture), their candidate etanercept biosimilar (SB4) has been found to be safe and well tolerated and to be equivalent in terms of efficacy compared to Enbrel (etanercept) in patients with rheumatoid arthritis (RA) [1].
