Biosimilars applications under review by EMA

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 13 April 2016 the agency is reviewing 10 biosimilar applications. One application is for diabetes treatment insulin glargine. Europe approved its first insulin glargine biosimilar Abasaglar (insulin glargine) in September 2014 [2].

The other applications are two for arthritis treatment adalimumab, two for blood-clot buster enoxaparin sodium, one for arthritis treatment etanercept, three are for neutropenia treatment pegfilgrastim and one is for leukaemia drug rituximab, for which there are currently no biosimilars available on the European market [3], see Table 1.

Table 1: Biosimilars under review by EMA*

Common name	Therapeutic area	Number of applications	Originator product(s)	Originator company
Adalimumab	Immunosuppressant	2	Humira	AbbVie
Enoxaparin sodium	Antithrombotic (blood-clot prevention)	2	Lovenox	Sanofi-Aventis
Etanercept	Immunosuppressant	1	Enbrel	Amgen
Insulin glargine	Diabetes	1	Lantus	Sanofi-Aventis
Pegfilgrastim	Immunostimulant	3	Neulasta	Amgen
Rituximab	Antineoplastic medicine (anticancer)	1	MabThera/Rituxan	Roche
Total		10
*Data collected on 3 May 2016. Source: EMA

On 19 November 2015, EMA’s CHMP announced that it had recommended approval of the etanercept biosimilar Benepali (SB4) from Samsung Bioepis [4]. This is the first etanercept biosimilar to be recommended for approval in Europe. On 8 December 2015, Sandoz, the generics division of Novartis, announced that their etanercept biosimilar (GP2015) had been accepted for review by EMA [5].

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

Since the last report entitled ‘Biosimilars applications under review by EMA – December 2015’ by GaBI Online, EMA’s CHMP recommended the approval of the marketing authorization for the infliximab biosimilar Flixabi (SB2), from Samsung Bioepis [8]. Europe approved the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) in September 2013 [9].

Generics applications under review by EMA - December 2015

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. 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 2016 May 6]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-etanercept-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
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 2016 May 6]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
8. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-infliximab-biosimilar-Flixabi
9. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 6]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar

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Source: EMA