Biosimilars
UK launches campaign to promote research on biosimilars
A new campaign launched by the UK’s National Institute for Health Research (NIHR) aims to unlock the potential benefits of biosimilars in the National Health Service (NHS) through clinical trials.
Phase III switching data support long-term efficacy and safety of rituximab biosimilar Truxima
Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) rituximab biosimilar (Truxima, CT-P10) is comparable to Roche’s MabThera/Rituxan, according to the South Korean biotechnology company.
Humira deal could cost CMS US$1.48 billion
The settlement deal made between US-based biotech giant Amgen and pharma giant AbbVie regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab) could cost the US Centers for Medicare and Medicaid Services (CMS) at least US$1.48 billion.
Physicochemical and biological characterization study of copy biological tocilizumab
Researchers in China have developed a copy biological of F. Hoffmann-La Roche’s (Roche) arthritis treatment Actemra (tocilizumab). A recent study compares it to the originator, finding it to be highly similar in terms of its physical, chemical and biological characteristics [1].
Australian prescribers’ views on biologicals naming and substitution
In a survey of 160 prescribers of biologicals in Australia, over three quarters agreed that the country’s Therapeutic Goods Administration (TGA) should insist on distinct non-proprietary scientific names for all biosimilars and reference products. The results of the survey were published just as TGA launched a public consultation on proposals for potential biological naming systems. A clear majority (98%) of prescribers who took part in the survey, run by the Alliance for Safe Biologic Medicines (ASBM), said they currently used either brand name or non-proprietary scientific names for recording and prescribing biosimilars and reference products [1]. Most (61%) wanted TGA to play a major role in naming biosimilars.
EMA accepts biosimilar pegfilgrastim application from Sandoz
Sandoz, the generics division of Novartis, announced on 27 October 2017 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).
Biosimilar insulins – reducing the cost of diabetes
Will biosimilar insulins be cheaper is a question raised by authors Lutz Heinemann and Alan Carter and one that they say is a clear yes [1].
Hospira to pay Amgen US$70 million for epoetin alfa patent infringement
US-based injectables specialist Hospira has been ordered to pay Biotech giant Amgen US$70 million in damages regarding a patent on Amgen’s anaemia blockbuster Epogen (epoetin alfa).
European perspective on biosimilars
In the European Union (EU), a legal framework for approving biosimilars was established in 2003. The first biosimilar Omnitrope (somatropin) was approved in 2006 [1].
FDA launches educational campaign for biosimilars
In light of the increasing number of biosimilars becoming available in the US, the US Food and Drug Administration (FDA) announced on 23 October 2017 the launch of its education campaign for biosimilars.
