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FDA approval for Amgen’s adalimumab biosimilar posted 30/09/2016

The US Food and Drug Administration (FDA) announced on 23 September 2016 that it had approved Amgen’s biosimilar version of A...

Australia says etanercept biosimilar can be substituted posted 30/09/2016

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has decided that the etanercept biosimilar Brenzys ‘could be ma...

FDA approves biosimilar etanercept Erelzi posted 23/09/2016

The US Food and Drug Administration (FDA) announced on 30 August 2016 that it had approved Sandoz’s biosimilar version of Amg...

Canadian approval for etanercept biosimilar posted 16/09/2016

Merck Canada announced on 12 September 2016 that it had received approval for its etanercept biosimilar Brenzys (SB4) from He...

Mylan and Biocon submit trastuzumab biosimilar to EMA posted 09/09/2016

Mylan and Biocon announced on 25 August 2016 that the regulatory submission for their proposed trastuzumab biosimilar (Myl-14...

 

Research

Switching may not be suitable for patients with immunogenicity posted 30/09/2016

Results of a study of antibodies to infliximab comparing both the originator (Remicade ) and biosimilar (Inflectra/Remsima; C...

Efficacy and safety of biosimilar infliximab in children with IBD posted 30/09/2016

Researchers from Birmingham Children’s Hospital presented results from a study of the use of the infliximab biosimilar CT-P13...

Positive phase III results for Sandoz etanercept biosimilar posted 23/09/2016

Results of a study of Sandoz’s etanercept biosimilar (GP2015) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etaner...

Study supports interchangeability of TNF-α biosimilars posted 20/09/2016

For years, the costs of drugs have been rising. Prescription drug spending in the US rose by 12.6% in 2014 and almost 1 in 4...

More positive phase I results for Coherus pegfilgrastim biosimilar posted 16/09/2016

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 11 July 2016 that follow-on results from a phase I...

 

General

Biosimilars of adalimumab posted 30/09/2016

Last update: 30 September 2016Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tu...

Biosimilars approved in the US posted 30/09/2016

Last update: 30 September 2016In the US, a legal framework for approving biosimilars was established in 2009, via the Bi...

Biosimilar User Fee Act reauthorization posted 23/09/2016

On 16 September 2016, the US Food and Drug Administration (FDA) released the Biosimilar User Fee Act II (BsUFA II) performanc...

Subsequent entry biologics approved in Canada posted 23/09/2016

Last update: 16 September 2016 In Canada, the regulatory body for the approval of biologicals is the Biologics and Genet...

Biosimilars of infliximab posted 23/09/2016

Last update: 16 September 2016Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α)....

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