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 September 2017, the agency is reviewing 12 biosimilar applications. Two applications are for cancer treatment bevacizumab and one is for diabetes treatment insulin glargine. Europe approved its first insulin glargine biosimilar Abasaglar (insulin glargine) in September 2014 [2]. Two applications are for neutropenia treatment pegfilgrastim and four are for breast cancer treatment trastuzumab.
The other applications are three 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
|
Originator product(s)
|
Originator company
|
| Adalimumab
|
Immunosuppressant
|
3
|
Humira
|
AbbVie
|
| Bevacizumab
|
Antineoplastic medicine (anticancer)
|
2
|
Avastin
|
Roche
|
| Infliximab
|
Immunosuppressant
|
1
|
Remicade
|
Johnson & Johnson/ Merck
|
| Insulin glargine
|
Diabetes
|
1
|
Lantus
|
Sanofi-Aventis
|
| Pegfilgrastim
|
Immunostimulant
|
2
|
Neulasta
|
Amgen
|
| Trastuzumab
|
Antineoplastic medicine (anticancer)
|
4
|
Herceptin
|
Roche
|
| Total
|
|
12
|
|
|
*Data collected on 7 Sep 2017
Source: EMA
|
On 21 April 2017, EMA’s CHMP announced that it had recommended approval of Sandoz’s etanercept biosimilar Elrezi (GP2015) [4]. The patents on the originator product Amgen/Pfizer’s Enbrel (etanercept) will expire in the US in November 2028, after Amgen was granted a new patent, and expired in Europe in August 2015 [5, 6].
Since the last report entitled ‘Biosimilars applications under review by EMA – April 2017’ by GaBI Online, EMA’s CHMP has also approved the rituximab biosimilars Rixathon and Riximyo, produced by Sandoz [4]. Sandoz’s insulin lispro biosimilar also gained EMA approval in May 2017 [7].
Related articles
Generics applications under review by EMA – April 2017
Biosimilars applications under review by EMA – April 2017
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 22]. 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 2017 Sep 22]. 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 2017 Sep 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. EMA approval for etanercept and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 22]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-etanercept-and-rituximab-biosimilars
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. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 22]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
7. GaBI Online - Generics and Biosimilars Initiative. EMA approval for insulin and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 22]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-insulin-and-rituximab-biosimilars
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