Biosimilars applications under review by EMA – 2013 Q3

Biosimilares/General | Posted 04/10/2013 post-comment0 Post your comment

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.

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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

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].

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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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