Biosimilars applications under review by EMA

Biosimilars/General | Posted 19/10/2012 post-comment0 Post your comment

Last update:  11 January 2013 

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 centralised 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 released in September 2012 the agency is reviewing 7 applications for marketing approval in the EU for biosimilars. The applications include one for filgrastim and three for human insulin, for which there are already biosimilars marketed in Europe [2]. The applications cover also two new products, follitropin alpha and infliximab, for which there are currently no biosimilars available on the European market, see Table 1.

Table 1: Biosimilars under review by EMA*

Common name Therapeutic area Number of applications Originator product Originator company
Filgrastim Immunostimulant (cancer/neutropenia) 1 Neupogen Amgen
Folliptropin alpha Sex hormones and modulators of the genital system (IVF treatment) 1 Gonal-F Merck Serono
Infliximab Immunosuppressant (arthritis) 2 Remicade Merck/Johnson & Johnson
Insulin human Diabetes 3 Humalog Eli Lilly
Total   7    
*Data collected on 27 September 2012; IVF = in vitro fertilization
Source: EMA

The European patents for Gonal-F (follitropin alpha), a recombinant hormone used in the treatment of infertility, already expired in 2009 leaving the path clear for a biosimilar competitor, while US patents do not expire until 2015. The drug is a major seller for Merck Serono, which posted worldwide sales for the second quarter of 2012 of US$161 million, representing growth of 17.7%.

The patents for Johnson & Johnson’s Remicade (infliximab) will expire in Europe in 2014 and in the US in 2018 [3].

South Korean biotechnology company Celltrion announced on 23 July 2012 that the Korean Food and Drug Administration (KFDA) had approved its first monoclonal antibody, Remsima.  The drug is a biosimilar of Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).  Celltrion has already applied to EMA for approval of Remsima in the EU [4].  Johnson & Johnson reported 2010 sales of US$8 billion for Remicade, making it a lucrative target.

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Generics applications under review by EMA

EMA receives second application for biosimilar infliximab


1.  GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 19]. Available from:

2.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 19]. Available from:

3.  GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 19]. Available from:

4.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 19]. Available from:

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Source: EMA, Merck, J&J

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