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Last update: 4 October 2013
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the 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 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 5 September 2013 the agency is reviewing two biosimilars applications. The applications include one for follitropin alfa, for which there was recently another biosimilar product approved for marketing in Europe [2]; and a new product, insulin glargine, for which there are currently no 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 | Originator company |
| Follitropin alfa | Sex hormones and modulators of the genital system (IVF treatment) | 1 | Gonal-F | Merck Serono |
| Insulin glargine | Diabetes | 1 | Lantus | Sanofi-Aventis |
| Total | 2 | |||
|
*Data collected on 3 October 2013; IVF = in vitro fertilization Source: EMA |
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The news that EMA is reviewing a biosimilar insulin product will come as a relief to diabetes sufferers in Europe [4], especially after the disappointing withdrawal of the applications for three biosimilar insulin products by Marvel LifeSciences in November 2012 [5].
Since the last report by GaBI Online for 2013 Q2, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a follitropin alfa biosimilar, Ovaleap, which is produced by generics giant Teva Pharmaceutical Industries (Teva) [2].
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 a biosimilar competitor. US patents, however, do not expire until 2015. The drug is one of Merck Serono’s top-three selling drugs, with 2012 sales of US$612 million, representing growth of 16%.
On 25 July 2013, EMA’s CHMP also adopted a positive opinion, recommending the granting of a marketing authorization for filgrastim biosimilar Grastofil, which is also produced by Apotex [6].
Related articles
Biosimilars applications under review by EMA – 2013 Q2
Generics applications under review by EMA – 2013 Q2
Biosimilars applications under review by EMA – 2013 Q1
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 4]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. EMA approves biosimilar follitropin alfa and somatropin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 4]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilar-follitropin-alfa-and-somatropin
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. EMA reviewing biosimilar insulin application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 4]. Available from: www.gabionline.net/Biosimilars/News/EMA-reviewing-biosimilar-insulin-application
5. GaBI Online - Generics and Biosimilars Initiative. Marvel withdraws biosimilar insulin applications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 4]. Available from: www.gabionline.net/Biosimilars/News/Marvel-withdraws-biosimilar-insulin-applications
6. GaBI Online - Generics and Biosimilars Initiative. Apotex breaking into the North American and European G-CSF markets [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 4]. Available from: www.gabionline.net/Biosimilars/News/Apotex-breaking-into-the-North-American-and-European-G-CSF-markets
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Source: EMA
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