Biosimilars applications under review by EMA – January 2019 Posted 25/01/2019

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 2019, the agency is reviewing 7 biosimilar applications. All applications are for products where there are already biosimilars approved in Europe.

Three applications are for arthritis treatment adalimumab, one is for arthritis treatment etanercept, one is for neutropenia treatment pegfilgrastim and two are for leukaemia drug rituximab, for which there are already biosimilars available on the European market [2], see Table 1.

Table 1: Biosimilars under review by EMA*

Common name

Therapeutic area

Number of applications

EMA-approved originator(s)

Originator company(ies)

Adalimumab

Immunosuppressant

3

Humira

AbbVie

Etanercept

Immunosuppressant

1

Enbrel

Amgen/Pfizer

Pegfilgrastim

Immunostimulant

1

Neulasta

Amgen

Rituximab

Antineoplastic medicine (anticancer)

2

MabThera/Rituxan

Roche

Total

 

7

 

 

*Data collected on 25 January 2019.
Source: EMA

In July 2018, trastuzumab biosimilar Trazimera (PF‑05280014) from Pfizer and three adalimumab biosimilars from Sandoz [Halimatoz, Hefiya and Hyrimoz (GP2017)] were approved by the European Commission (EC) [3].

In September 2018, Mylan’s adalimumab biosimilar, Hulio, and ERA Consulting’s (Coherus Biosciences) pegfilgrastim biosimilar, Udenyca, received EC approval [4].

In November 2018, pegfilgrastim biosimilars, Fulphila, Pelmeg and Ziextenzo, received EC approval. Pelmeg (B12019) is made by UK-based Mundipharma International (Mundipharma) and Spanish biosimilars’ developer Cinfa Biotech. Ziextenzo (LA‑EP2006) is manufactured by Sandoz, the generics division of Novartis [5]. Fulphila (MYL‑1401H) is made by US-based drugmaker Mylan [2].

Mylan’s trastuzumab biosimilar, Ogivri (MYL-1401O), gained EC approval in December 2018 [2]. EMA’s CHMP also announced that it had recommended granting marketing authorization for Pfizer’s bevacizumab biosimilar Zirabev [5].

Related articles
Generics applications under review by EMA – January 2019

Biosimilars applications under review by EMA – June 2018

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. 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 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars gain EC approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-gain-EC-approval
4. GaBI Online - Generics and Biosimilars Initiative. EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-pegfilgrastim-biosimilars-Pelmeg-and-Ziextenzo
5. GaBI Online - Generics and Biosimilars Initiative. EMA approval for bevacizumab biosimilar Zirabev [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 25]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-bevacizumab-biosimilar-Zirabev

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