Biosimilars applications under review by EMA

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Biosimilars applications under review by EMA – 2012 Q4

Biosimilares/General | Posted 11/01/2013 0 Post your comment

Last update: 23 August 2013

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 released in December 2012, the agency is reviewing eight 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 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
Filgrastim	Immunostimulant (cancer/neutropenia)	1	Neupogen	Amgen
Follitropin 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	Humalin S	Eli Lilly
r-FSH follitropin alpha	Sex hormones and modulators of the genital system (IVF treatment)	1	Gonal-F	Merck Serono
Total		8
Data collected on 10 January 2013; IVF: in vitro* fertilization; r-FSH: recombinant follicle stimulating hormone. Source: EMA

EMA’s list of biosimilars under review for December 2012 (dated 29 November 2012) still includes three insulin products. However, on 27 November 2012 Marvel LifeSciences (Marvel) announced the withdrawal of its biosimilar human insulin applications for Combimarv, Isomarv and Solumarv [3]. The three biosimilar insulins listed on EMA’s list could therefore be three new products, or could still be Marvel’s products – with the official withdrawal only being recorded after EMA’s CHMP meeting of 10–13 December 2012.

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 [4].

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 [5]. Johnson & Johnson reported 2010 sales of US$8 billion for Remicade, making it a lucrative target.

Related articles

Finox submits r-FSH biosimilar application to EMA

Generics applications under review by EMA

EMA receives second application for biosimilar infliximab

References

1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jan 11]. 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 Jan 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

3. GaBI Online - Generics and Biosimilars Initiative. Marvel withdraws biosimilar insulin applications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jan 18]. Available from: www.gabionline.net/Biosimilars/News/Marvel-withdraws-biosimilar-insulin-applications

4. 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 Jan 11]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

5. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jan 11]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: EMA, Merck, J&J