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 9 July 2019, the agency is reviewing 11 biosimilar applications. All applications are for products where there are already biosimilars approved in Europe.
One application is for arthritis treatment adalimumab, one is for arthritis treatment etanercept, one is for diabetes treatment insulin aspart, three are for leukaemia drug rituximab, three are for osteoporosis treatment teriparatide and two are for breast and gastric-cancer treatment trastuzumab, for which there are already biosimilars available on the European market [2], see Table 1.
| Table 1: Biosimilars under review by EMA*
|
| Common name
|
Therapeutic area
|
Number of applications
|
EMA-approved originator(s)
|
Originator company(ies)
|
| Adalimumab
|
Immunosuppressant
|
1
|
Humira
|
AbbVie
|
| Etanercept
|
Immunosuppressant
|
1
|
Enbrel
|
Amgen/Pfizer
|
| Insulin aspart
|
Diabetes
|
1
|
NovoLog
|
Novo Nordisk
|
| Rituximab
|
Antineoplastic medicine (anticancer)
|
3
|
MabThera/Rituxan
|
Roche
|
| Teriparatide
|
Calcium homeostasis
|
3
|
Forteo/Forsteo
|
Eli Lilly
|
| Trastuzumab
|
Antineoplastic medicines
|
2
|
Herceptin
|
Roche
|
| Total
|
|
11
|
|
|
| *Data collected on 26 July 2019. Source: EMA.
|
In January 2019, the pegfilgrastim biosimilar, Fulphila, received European Commission approval [3].
In July 2019, Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced that the application for approval of its proposed bevacizumab biosimilar SB8 has been accepted for review by EMA [4].
In April 2019, the adalimumab biosimilars Idacio and Kromaya received European approval for all the indications of the reference product (Humira) [5, 6].
Related articles
Generics applications under review by EMA – July 2019
Biosimilars applications under review by EMA – January 2019
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3 GaBI Online - Generics and Biosimilars Initiative. EC approval for pegfilgrastim biosimilar Fulphila [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-pegfilgrastim-biosimilar-Fulphila
4 GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for bevacizumab biosimilar from Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 16]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-bevacizumab-biosimilar-from-Samsung-Bioepis
5 GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Idacio and Kromeya [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 16]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Idacio-and-Kromeya
6 GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab biosimilar Idacio [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 16]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-biosimilar-Idacio
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