Biosimilars/General

Biosimilars applications under review by EMA – August 2016

Biosimilars/General | Posted 09/09/2016

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.

Biosimilars of basiliximab

Biosimilars/General | Posted 26/08/2016

Basiliximab is a chimeric mouse-human monoclonal antibody to the α chain (CD25) of the IL-2 receptor of T cells. It is an immunosuppresant agent used to prevent immediate transplant rejection in people who are receiving kidney transplants, in combination with other agents.

WHO naming of biosimilars

Biosimilars/General | Posted 25/10/2013

The World Health Organization (WHO) has proposed a system of naming for biosimilars, which has been commended by some groups [1], but criticized by others.

Sandoz plans to launch five more biosimilars by 2020

Biosimilars/General | Posted 12/08/2016

Sandoz, the generics division of Novartis, has announced plans for five major global biosimilar launches by 2020.

Roche sues India’s drug regulator over Avastin ‘similar biologics’

Biosimilars/General | Posted 03/06/2016

Switzerland-based drug giant Roche has sued the Drug Controller General of India (DCGI) in the Delhi High Court over ‘similar biologic’ versions of its cancer blockbuster Avastin (bevacizumab).

Japan proving to be a favourable market for biosimilars

Biosimilars/General | Posted 20/05/2016

Uptake of biosimilars in Japan is on a par with generics use for some products, making Japan a lucrative market for biosimilars makers.

Benepali wins Danish tender for etanercept

Biosimilars/General | Posted 13/05/2016

Denmark’s drug procurement agency Amgros has chosen the etanercept biosimilar Benepali, made by Samsung Bioepis, as the priority drug for treating rheumatoid arthritis rather than the originator biological (Amgen’s Enbrel).

Biosimilars applications under review by EMA – April 2016

Biosimilars/General | Posted 06/05/2016

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

Biosimilars/General | Posted 05/02/2016

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

Biosimilars/General | Posted 29/01/2016

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.