Biosimilars
Study design for biosimilar trials
Biosimilars have been available in the field of rheumatology since 2015. In light of this fact, researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss study design for biosimilar trials [1].
Biogen’s infliximab biosimilar gets UK launch
US biotechnology company Biogen has launched their biosimilar of blockbuster anti-inflammatory Remicade (infliximab) across the UK.
NOR-SWITCH study finds biosimilar infliximab not inferior to originator
Results of a two-year phase IV study have shown that Celltrion Healthcare (Celltrion)’s infliximab biosimilar (Remsima, CT-P13) is not inferior to the originator biological Remicade.
Biosimilars versus generics
Since 2015, biosimilars have been available in the field of rheumatology. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London discuss how such biosimilars differ from the more traditional generics [1].
Pfizer to launch infliximab biosimilar Inflectra in US
Pfizer announced on 17 October 2016 that it will begin shipment of its monoclonal antibody biosimilar Inflectra (infliximab-dyyb) to the US in late November 2016.
Merck launches biosimilars educational resource for patients
US pharma giant Merck (known as MSD outside the US and Canada) has launched an online resource intended to be used as an educational platform for patients, caregivers and the healthcare community.
Use of biosimilar anti-TNF in Australia
With the advent of biosimilar anti-tumour necrosis factor (TNF), new options have opened up for the treatment of inflammatory bowel disease (IBD) in Australia. Author Richard B Gearry of the University of Otago, Christchurch, New Zealand, discusses what needs to be taken into consideration when physicians prescribe anti-TNF products [1].
Teva and Celltrion to partner on biosimilars
Israeli generics giant Teva Pharmaceutical Industries (Teva) and South Korean biotechnology company Celltrion announced on 7 October 2016 that they had entered into an exclusive partnership for two of Celltrion’s monoclonal antibody biosimilars in the US and Canada.
Positive phase III results for Mylan’s biosimilar pegfilgrastim
Results of a study of Biocon and Mylan’s comparing Biocon/Mylan’s biosimilar pegfilgrastim (MYL-1401H) to the originator (Neulasta) has ‘demonstrated equivalent efficacy’, according to Mylan [1].
Court rules in favour of Apotex in biosimilars dispute
Biosimilars specialist Apobiologix, which is part of the Apotex group, announced on 9 September 2016 that it had won its battle in the US against biologicals giant Amgen with respect to its filgrastim (Grastofil) and pegfilgrastim (Lapelga) biosimilars.
