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Biosimilars applications under review by EMA – January 2020 Posted 31/01/2020

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 7 January 2020, the agency is reviewing 14 biosimilar applications. All applications are for products where there are already biosimilars approved in Europe.

Two applications are for cancer treatment bevacizumab, one is for arthritis treatment etanercept, two are for diabetes treatment insulin aspart, one for neutropenia (low white blood cells) treatment pegfilgrastim, three are for leukaemia drug rituximab, three are for osteoporosis treatment teriparatide and two are for breast and gastric-cancer treatment trastuzumab, for which there are already biosimilars available on the European market [2], see Table 1.

Table 1: Generics under review by EMA*

Common name

Therapeutic area

Number of applications

EMA approved originator(s)

Originator company(ies)

Bevacizumab

Antineoplastic medicine (anticancer)

2

Avastin

Roche

Etanercept

Immunosuppressant (arthritis)

1

Enbrel

Amgen/Pfizer

Insulin aspart

Diabetes

2

NovoLog

Novo Nordisk

Pegfilgrastim

Immunostimulant (neutropenia)

1

Neulasta

Amgen

Rituximab

Antineoplastic medicine (anticancer)

3

MabThera/Rituxan

Roche

Teriparatide

Calcium homeostasis (osteoporosis)

3

Forteo/Forsteo

Eli Lilly

Trastuzumab

Antineoplastic medicines

2

Herceptin

Roche

Total

 

14

   

*Data collected on 31 January 2020
Source: EMA

EMA’s CHMP approved adalimumab biosimilars Idacio and Kromeya, both made by Fresenius Kabi, the generics unit of German healthcare giant Fresenius, in January 2019 [3].

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Biosimilars applications under review by EMA – July 2019

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. 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 2020 Jan 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
3. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Idacio and Kromeya [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 31]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Idacio-and-Kromeya

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Source: EMA

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