Biosimilars/General
Biosimilars applications under review by EMA – April 2016
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Biosimilar etanercept offered at 47% discount in Norway
Samsung Bioepis confirmed on 1 February 2016 that it had won a contract in Norway to supply its newly approved biosimilar etanercept, Benepali, to the country.
Biosimilars applications under review by EMA – December 2015
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Biosimilars applications under review by EMA – August 2015
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Biosimilars applications under review by EMA – April 2015
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Biosimilars on the horizon
Europe approved its first monoclonal antibody biosimilar, Inflectra/Remsima (infliximab), in September 2013 [1]. But how does the pipeline look for biosimilars and what will be the next biosimilar to be approved?
Biosimilars group launched in UK to improve biosimilars uptake
On 18 April 2016, the British Generic Manufacturers Association (BGMA) announced the launch of its expert sector group on biosimilars, the British Biosimilars Association (BBA).
US rheumatologists in favour of distinct names for biosimilars
Following the approval of the infliximab biosimilar Inflectra (infliximab-dyyb) the American College of Rheumatology (ACR) has issued a statement supporting the use of distinct names for biosimilars.
IPRF template for summary information for biosimilar reviews
The Biosimilars Working Group (BWG) of the International Pharmaceutical Regulators Forum (IPRF) has released a template for Public Assessment Summary Information for Biosimilar (PASIB).
IGBA opposes WHO biological qualifier
The World Health Organization (WHO) is considering a proposal to assign Biological Qualifiers (BQs), which are random alphabetic codes, to help standardize the naming of biologicals, including biosimilars [1]. However, not everyone agrees with their proposal.
