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Last update: 17 January 2014
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 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 18 December 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 7 January 2014; 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].
A follitropin alfa biosimilar, Ovaleap, which is produced by generics giant Teva Pharmaceutical Industries (Teva), received marketing authorization in the EU on 27 September 2013 [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%.
Since the last report by GaBI Online for 2013 Q3, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has not accepted any new applications for biosimilar marketing approval in Europe.
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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 Jan 17]. 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 2014 Jan 17]. 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 2014 Jan 17]. 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 2014 Jan 17]. 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 2014 Jan 17]. Available from: www.gabionline.net/Biosimilars/News/Marvel-withdraws-biosimilar-insulin-applications
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Source: EMA
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