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Biosimilars applications under review by EMA – December 2016 Posted 13/01/2017

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 submitted 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 2 December 2016, the agency is reviewing 16 biosimilar applications. One application is for diabetes treatment insulin glargine. Europe approved its first insulin glargine biosimilar Abasaglar (insulin glargine) in September 2014 [2]. Two applications are for leukaemia drug rituximab. EMA’s CHMP gave a positive opinion for Celltrion’s rituximab biosimilar Truxima (CT-P10) on 15 December 2016 [3].

The other applications are four for arthritis treatment adalimumab, two for arthritis treatment etanercept, one for fast acting insulin analog insulin lispro, three for neutropenia treatment pegfilgrastim and three for breast cancer treatment trastuzumab, for which there are currently no biosimilars available on the European market [4], see Table 1.

Table 1: Biosimilars under review by EMA*

Common name

Therapeutic area

Number of applications

Originator product(s)

Originator company

Adalimumab

Immunosuppressant

4

Humira

AbbVie

Etanercept

Immunosuppressant

2

Enbrel

Amgen

Insulin glargine

Diabetes

1

Lantus

Sanofi-Aventis

Insulin lispro

Diabetes

1

Humalog

Eli Lilly

Pegfilgrastim

Immunostimulant

3

Neulasta

Amgen

Rituximab

Antineoplastic medicine (anti-cancer)

2

MabThera/Rituxan

Roche

Trastuzumab

Antineoplastic medicine (anti-cancer)

3

Herceptin

Roche

Total

 

16

 

 

*Data collected on 12 January 2017
Source: EMA

On 1 April 2016, EMA’s CHMP announced that it had recommended approval of the infliximab biosimilar Flixabi (SB2), from Samsung Bioepis [5]. Europe approved the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) in September 2013 [6].

The patents on the originator product Remicade (infliximab) expired in Europe in February 2015 and will expire in the US in November 2018 [7].

Since the last report entitled Biosimilars applications under review by EMA – August 2016 by GaBI Online, the CHMP has announced that applications for marketing authorizations for the pegfilgrastim biosimilars Cavoley and Efgratin have been withdrawn. The CHMP also gave a positive opinion for Celltrion’s rituximab biosimilar Truxima (CT-P10) [3].

Related articles
Generics applications under review by EMA - August 2016

Biosimilars applications under review by EMA – August 2016

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
3. GaBI Online - Generics and Biosimilars Initiative. EMA approval for rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. 
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-infliximab-biosimilar-Flixabi
6. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 13]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries

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Source: EMA

Comments (2)

Response to ‘Lifmior is not a biosimilar’ posted 19/01/2017 - by Louis B, GaBI Online Editorial Office

Thank you for your comment on 17/01/2017. We have now updated the article on the website. Best Regards, Louis

Lifmior is not a biosimilar posted 17/01/2017 - by Paul Declerck

Please note that Lifmior(R) (etanercept) is not a biosimilar of Enbrel(R) but identical to Enbrel (it is a 'duplicate' dossier from the same MAH !).