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Biosimilars/General

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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.

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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.

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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.

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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).

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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.

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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).

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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.

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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.

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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.

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Biosimilars applications under review by EMA – August 2015

Biosimilars/General | Posted 18/09/2015

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.

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Biosimilars applications under review by EMA – April 2015

Biosimilars/General | Posted 05/06/2015

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.

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Biosimilars on the horizon

Biosimilars/General | Posted 23/05/2014

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?

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Biosimilars group launched in UK to improve biosimilars uptake

Biosimilars/General | Posted 29/04/2016

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).

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US rheumatologists in favour of distinct names for biosimilars

Biosimilars/General | Posted 22/04/2016

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.

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IPRF template for summary information for biosimilar reviews

Biosimilars/General | Posted 01/04/2016

The Biosimilars Working Group (BWG) of the International Pharmaceutical Regulators Forum (IPRF) has released a template for Public Assessment Summary Information for Biosimilar (PASIB).

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IGBA opposes WHO biological qualifier

Biosimilars/General | Posted 25/03/2016

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.

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US doctors poised to prescribe biosimilars

Biosimilars/General | Posted 18/03/2016

A survey of specialists in the US has found that nearly half of them expect to prescribe biosimilars to treatment-naïve patients.

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Amgen sues Sandoz over etanercept biosimilar

Biosimilars/General | Posted 11/03/2016

Following the submission of application for approval of its etanercept biosimilar in the US, Sandoz is coming under fire from originator company Amgen.

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Sandoz acquires EEA rights to infliximab biosimilar from Pfizer

Biosimilars/General | Posted 04/03/2016

Sandoz, the generics division of Novartis, announced on 12 February 2016 that it had acquired the rights for the development and commercialization of Pfizer’s biosimilar infliximab (PF-06438179) in the European Economic Area (EEA), which includes the 28 countries of the European Union (EU), plus Iceland, Liechtenstein and Norway.

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FDA releases ‘Overview of Biosimilar Products’

Biosimilars/General | Posted 26/02/2016

As part of its ongoing mission to educate industry, the public and healthcare professionals about biosimilars, the US Food and Drug Administration (FDA) has released an online educational course for healthcare professionals.