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 25 April 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 8 May 2014
Source: EMA
The news that EMA is reviewing a biosimilar insulin product will come as a relief to diabetes sufferers in Europe [3], especially after the disappointing withdrawal of the applications for three biosimilar insulin products by Marvel LifeSciences in November 2012 [4].
A second follitropin alfa biosimilar, Bemfola, produced by Switzerland-based Finox Biotech, received a positive opinion from EMA’s CHMP on 23 January 2014, recommending the granting of a marketing authorization in the EU [5]. Bemfola is intended for the treatment of fertility disorders.
The European patents for the originator product, Gonal-F (follitropin alfa), a recombinant hormone used in the treatment of infertility, already expired in 2009 leaving the path clear for biosimilars competitors. US patents, however, do not expire until 2015. The drug is one of Merck Serono’s top-three selling drugs, with 2013 sales of US$586 million.
Since the last report by GaBI Online for 2013 Q4, EMA’s Committee for Medicinal Products for Human Use (CHMP) has not accepted any new applications for biosimilar marketing approvals in Europe.
Related articles
Generics applications under review by EMA – April 2014
Generics applications under review by EMA – 2013 Q4
Biosimilars applications under review by EMA – 2013 Q4
Biosimilars approved in Europe
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 16]. 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 May 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EMA reviewing biosimilar insulin application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 16]. Available from: www.gabionline.net/Biosimilars/News/EMA-reviewing-biosimilar-insulin-application
4. GaBI Online - Generics and Biosimilars Initiative. Marvel withdraws biosimilar insulin applications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 16]. Available from: www.gabionline.net/Biosimilars/News/Marvel-withdraws-biosimilar-insulin-applications
5. GaBI Online - Generics and Biosimilars Initiative. EMA approves follitropin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 16]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-follitropin-alfa-biosimilar
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