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 8 September 2014 the agency is reviewing one biosimilar application. The application is for insulin glargine, for which there are currently no biosimilars available on the European market [2], see Table 1.
Table 1: Biosimilars under review by EMA*
| Common name
|
Therapeutic area
|
Number of applications
|
Originator product
|
Originator company
|
| Insulin glargine
|
Diabetes
|
1
|
Lantus
|
sanofi-aventis
|
| Total
|
|
1
|
|
|
| *Data collected on 16 September 2014. Source: EMA
|
EMA’s list of medicines under review still states that the agency is reviewing one insulin glargine biosimilar. However, since the last report by GaBI Online for April 2014, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for an insulin glargine biosimilar, Abasria (LY2963016), which is produced by partners Eli Lilly and Boehringer Ingelheim [3]. The companies subsequently announced on 10 September 2014 that they had also received European Commission approval for Abastria [4].
On 18 August 2014 the US Food and Drug Administration (FDA) also granted tentative approval for Eli Lilly and Boehringer Ingelheim’s insulin glargine product, which will be called Basaglar (LY2963016) in the US. The application for approval of Basaglar in the US, however, was submitted to FDA using a new drug application and not via the abbreviated biosimilars pathway [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 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 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EMA approves biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilar-insulin
4. GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
5. GaBI Online - Generics and Biosimilars Initiative. FDA grants tentative approval for insulin treatment [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/News/FDA-grants-tentative-approval-for-insulin-treatment
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