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 January 2018, the agency is reviewing 16 biosimilar applications. One application is for diabetes treatment insulin glargine. Europe approved its first insulin glargine biosimilar Abasaglar (insulin glargine) in September 2014 [2]. Six applications are for neutropenia treatment pegfilgrastim and three are for breast cancer treatment trastuzumab.
The other applications are five for arthritis treatment adalimumab and one for arthritis treatment infliximab, for which there are already biosimilars available on the European market [3], 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
|
5
|
Humira
|
AbbVie
|
| Infliximab
|
Immunosuppressant
|
1
|
Remicade
|
Johnson & Johnson/Merck
|
| Insulin glargine
|
Diabetes
|
1
|
Lantus
|
Sanofi-Aventis
|
| Pegfilgrastim
|
Immunostimulant
|
6
|
Neulasta
|
Amgen
|
| Trastuzumab
|
Antineoplastic medicine (anticancer)
|
3
|
Herceptin
|
Roche
|
| Total
|
|
16
|
|
|
| *Data collected on 19 January 2018. Source: EMA
|
On 10 November 2017, EMA’s CHMP announced that it had recommended approval of Amgen/Allergan’s bevacizumab biosimilar Mvasi (ABP 215) [4]. The patents on the originator product Roche’s Avastin (bevacizumab) will expire in the US in July 2019 and in Europe in January 2022 [5].
Then on 20 November 2017, South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced that it had received European Commission (EC) approval for its biosimilar trastuzumab product Ontruzant (SB3) [6].
Related articles
Generics applications under review by EMA – January 2018
Biosimilars applications under review by EMA – August 2017
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 19]. 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 2018 Jan 19]. 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 2018 Jan 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. EMA approval for bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 19]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-bevacizumab-biosimilar-Mvasi
5. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
6. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 19]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant
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