Biosimilars
EMA accepts application for trastuzumab biosimilar
Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 3 October 2016 that its regulatory submission for its proposed trastuzumab biosimilar (SB3) had been accepted for review by the European Medicines Agency (EMA). The company says the marketing application was submitted in August 2016.
Biosimilars in rheumatology
In 2015, the rheumatology community saw the emergence of the first biosimilars onto the market. Biosimilars are not new to the medical community at large, having been on the market in the European Union (EU) since 2006. However, their arrival into the field of rheumatology is new and, according to researchers from the National Health Service (NHS) Foundation Trust and King's College London, ‘comes with great anticipation’ [1].
FDA approval for Amgen’s adalimumab biosimilar
The US Food and Drug Administration (FDA) announced on 23 September 2016 that it had approved Amgen’s biosimilar version of AbbVie’s arthritis blockbuster Humira (adalimumab).
Switching may not be suitable for patients with immunogenicity
Results of a study of antibodies to infliximab comparing both the originator (Remicade ) and biosimilar (Inflectra/Remsima; CT-P13) versions has shown ‘cross-immunogenicity’ between the originator and biosimilar in patients with rheumatic diseases [1].
Efficacy and safety of biosimilar infliximab in children with IBD
Researchers from Birmingham Children’s Hospital presented results from a study of the use of the infliximab biosimilar CT-P13 (Remsima/Inflectra) in children with inflammatory bowel disease (IBD) [1].
Australia says etanercept biosimilar can be substituted
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has decided that the etanercept biosimilar Brenzys ‘could be marked as equivalent’ to the brand-name biological Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS).
Biosimilar User Fee Act reauthorization
On 16 September 2016, the US Food and Drug Administration (FDA) released the Biosimilar User Fee Act II (BsUFA II) performance goals letter, attracting support from industry associations.
FDA approves biosimilar etanercept Erelzi
The US Food and Drug Administration (FDA) announced on 30 August 2016 that it had approved Sandoz’s biosimilar version of Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept).
Positive phase III results for Sandoz etanercept biosimilar
Results of a study of Sandoz’s etanercept biosimilar (GP2015) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) have shown ‘equivalent efficacy’, according to the company.
Canadian approval for etanercept biosimilar
Merck Canada announced on 12 September 2016 that it had received approval for its etanercept biosimilar Brenzys (SB4) from Health Canada – the first subcutaneous anti-tumour necrosis factor (anti-TNF) biosimilar available in Canada.
