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 6 June 2018, the agency is reviewing 13 biosimilar applications. One application is for arthritis treatment etanercept, eight applications are for neutropenia treatment pegfilgrastim, and one is for breast cancer treatment trastuzumab.
The other applications are two for arthritis treatment adalimumab and one for cancer treatment bevacizumab; see Table 1, for which there are already biosimilars available on the European market [2].
| Table 1: Biosimilars under review by EMA*
|
| Common name
|
Therapeutic area
|
Number of applications
|
EMA-approved originator(s)
|
Originator company(ies)
|
| Adalimumab
|
Immunosuppressant
|
2
|
Humira
|
AbbVie
|
| Bevacizumab
|
Antineoplastic medicine (anticancer)
|
1
|
Avastin
|
Roche
|
| Etanercept
|
Immunosuppressant
|
1
|
Enbrel
|
Amgen/Pfizer
|
| Pegfilgrastim
|
Immunostimulant
|
8
|
Neulasta
|
Amgen
|
| Trastuzumab
|
Antineoplastic medicine (anticancer)
|
1
|
Herceptin
|
Roche
|
| Total
|
|
13
|
|
|
| *Data collected on 5 July 2018. Source: EMA
|
South Korean biotechnology company Celltrion announced on 14 February 2018 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Herzuma (CT‑P6) [3].
The EMA’s CHMP announced on 23 March 2018 that it had recommended approval of Biotech giant Amgen and partner Allergan’s trastuzumab biosimilar Kanjinti (ABP 980) [4].
India-based Biocon and US-based partner Mylan announced on 28 March 2018 that they had received EC approval for their co-developed insulin glargine biosimilar, Semglee (MYL‑1501D) [5].
On 24 May 2018, Sandoz, the generics division of Novartis, announced that it had received EC approval for its infliximab biosimilar Zessly (PF‑06438179) [6].
Then on 1 June 2018, EMA’s CHMP announced that it had recommended approval of Sandoz’s adalimumab biosimilars Halimatoz, Hefiya and Hyrimoz (GP2017). On the same date, the CHMP also recommended approval of Pfizer’s trastuzumab biosimilar Trazimera (PF‑05280014) [7].
Related articles
Biosimilars applications under review by EMA – January 2018
Generics applications under review by EMA – January 2018
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. 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 2018 Jul 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Herzuma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Herzuma
4. GaBI Online - Generics and Biosimilars Initiative. EMA approval for trastuzumab biosimilar Kanjinti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-trastuzumab-biosimilar-Kanjinti
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for infliximab biosimilar Zessly [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-infliximab-biosimilar-Zessly
6. GaBI Online - Generics and Biosimilars Initiative. Insulin biosimilar Semglee gains EC and Australian approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Biosimilars/News/Insulin-biosimilar-Semglee-gains-EC-and-Australian-approval
7. GaBI Online - Generics and Biosimilars Initiative. EMA approves adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-adalimumab-and-trastuzumab-biosimilars
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