Last update: 12 April 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 .
According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in March 2013, the agency is reviewing five applications for marketing approval in the EU for biosimilars. The applications include one for filgrastim, for which there are already biosimilars marketed in Europe . The applications also cover 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
|| Immunostimulant (cancer/neutropenia)
| Follitropin alpha
|| Sex hormones and modulators of the genital system (IVF treatment)
|| Merck Serono
|| Immunosuppressant (arthritis)
|| Merck/Johnson & Johnson
*Data collected on 11 April 2013; IVF = in vitro fertilization
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 .
South Korean biotechnology company Celltrion announced on 23 July 2012 that the Korean Food and Drug Administration 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 . Johnson & Johnson reported 2010 sales of US$8 billion for Remicade, making it a lucrative target.
Generics applications under review by EMA – 2013 Q1
Biosimilars applications under review by EMA – 2012 Q4
Biosimilars applications under review by EMA
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 12]. 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 2013 Apr 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 12]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 12]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea
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