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 3 August 2016 the agency is reviewing 11 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 three for arthritis treatment adalimumab, one for arthritis treatment etanercept, four are for neutropenia treatment pegfilgrastim and two are 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
|
3
|
Humira
|
AbbVie
|
| Etanercept
|
Immunosuppressant
|
1
|
Enbrel
|
Amgen
|
| Insulin glargine
|
Diabetes
|
1
|
Lantus
|
Sanofi-Aventis
|
| Pegfilgrastim
|
Immunostimulant
|
4
|
Neulasta
|
Amgen
|
| Rituximab
|
Antineoplastic medicine (anticancer)
|
2
|
MabThera/Rituxan
|
Roche
|
| Total
|
|
11
|
|
|
*Data collected on 2 September 2016.
Source: EMA
|
On 1 April 2016 the EMA’s CHMP announced that it had recommended approval of the infliximab biosimilar Flixabi (SB2), from Samsung Bioepis [4]. Europe approved the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) in September 2013 [5].
The patents on the originator product Remicade (infliximab) expired in Europe in February 2015 and will expire in the US in November 2018 [6].
Since the last report entitled ‘Biosimilars applications under review by EMA – April 2016’ by GaBI Online, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of marketing authorizations for the low molecular weight heparin blood-clot buster enoxaparin sodium from Pharmathen and Techdow Europe.
Related articles
Generics applications under review by EMA - April 2016
Biosimilars applications under review by EMA – April 2016
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 9]. 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 Sep 9]. 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 Sep 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 9]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-infliximab-biosimilar-Flixabi
5. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 9]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
6. Derbyshire M. Patent expiry dates for best-selling biologicals, Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
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