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 4 December 2015 the agency is reviewing seven biosimilar applications. One application is for arthritis treatment infliximab. Europe approved the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) in September 2013 [2].

The other applications are two for blood-clot buster enoxaparin sodium, one for arthritis treatment etanercept, two are for neutropenia treatment pegfilgrastim and one 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
Enoxaparin sodium	Antithrombotic (blood-clot prevention)	2	Lovenox	Sanofi-Aventis
Etanercept	Immunosuppressant	1	Enbrel	Amgen
Infliximab	Immunosuppressant	1	Remicade	Johnson & Johnson
Pegfilgrastim	Immunostimulant	2	Neulasta	Amgen
Rituximab	Antineoplastic medicine (anticancer)	1	Mab Thera/Rituxan	Roche
Total		7
*Data collected on 29 January 2016 Source: EMA

On 19 November 2015, 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. Then, 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) 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].

Since the last report entitled Biosimilars applications under review by EMA – August 2015 by GaBI Online, CHMP has recommended the refusal of the marketing authorization for the human insulin biosimilar Solumarv, from Marvel Life Sciences. The main reason stated for this refusal was that the company did not define the manufacturing process for Solumarv in sufficient detail. CHMP therefore concluded that it was not possible to show that Solumarv used in clinical studies was representative of batches intended for the market and that its quality was comparable to that of Humulin S (the reference product).

References
1.   GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. 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 Jan 29]. 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 Jan 29]. 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 Jan 29]. 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 Jan 29]. 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 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-submits-second-biosimilar-to-EMA

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Source: EMA