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Biosimilars applications under review by EMA – April 2015

Biosimilars/General | Posted 05/06/2015 0 Post your comment

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.

All medicines for human and animal use derived from biotechnology and other high-tech processes (including biosimilars) must be approved via the centralized EMA procedure. EMA has both general and product specific guidelines giving information on the requirements for biosimilar applications submitted to EMA [1].

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP) released on 7 April 2015 the agency is reviewing four biosimilar applications. One application is for diabetes treatment, human insulin. An insulin glargine biosimilar, Abasaglar (previously Abasria), was approved in the EU on 9 September 2014 [2]. Another application is for arthritis treatment infliximab. Europe approved the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) in September 2013 [3].

The other applications are for blood-clot buster enoxaparin sodium and for arthritis treatment etanercept, for which there are currently no biosimilars available on the European market [4], see Table 1.

Table 1: Biosimilars under review by EMA*

Common name	Therapeutic area	Number of applications	Originator product	Originator company
Enoxaparin sodium	Antithrombotic (blood-clot prevention)	1	Lovenox	Sanofi
Etanercept	Immunosuppressant	1	Enbrel	Amgen
Human insulin	Diabetes	1	Insuman	Sanofi-Aventis
Infliximab	Immunosuppressant	1	Remicade	Johnson & Johnson
Total		4
*Data collected on 2 June 2015. Source: EMA

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 21 January 2015 that its etanercept biosimilar candidate, SB4, had been accepted for review by EMA [5]. This is the first application for an etanercept biosimilar to be accepted for review by EMA.

The patents on the originator product Enbrel (etanercept) are set to expire in Europe in February 2015, but will only expire in the US in November 2028 after Amgen was granted a new patent [6, 7].

Samsung Bioepis also announced on 13 March 2015 that its infliximab biosimilar candidate, SB2, had been accepted for review by EMA [8].

References
1.   GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 5]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
2.   GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 5]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
3.   GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 5]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
4.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5.   GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept submitted for approval in EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 5]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-etanercept-submitted-for-approval-in-EU
6.   GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 5]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
7.   GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 5]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
8.   GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis submits second biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 5]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-submits-second-biosimilar-to-EMA

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Source: EMA