Biosimilars applications under review by EMA

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 4 April 2017, the agency is reviewing 18 biosimilar applications. One application is for cancer treatment bevacizumab and one is for diabetes treatment insulin glargine. Europe approved its first insulin glargine biosimilar Abasaglar (insulin glargine) in September 2014 [2]. Five 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]. One application is for fast acting insulin analogue insulin lispro, two are for neutropenia treatment pegfilgrastim and three are for breast cancer treatment trastuzumab.

The other applications are two for arthritis treatment adalimumab and one for arthritis treatment etanercept, for which there are already 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	2	Humira	AbbVie
Bevacizumab	Antineoplastic medicine (anticancer)	2	Avastin	Roche
Etanercept	Immunosuppressant	1	Enbrel	Amgen
Insulin glargine	Diabetes	1	Lantus	Sanofi-Aventis
Insulin lispro	Diabetes	1	Humalog	Eli Lilly
Pegfilgrastim	Immunostimulant	2	Neulasta	Amgen
Rituximab	Antineoplastic medicine (anticancer)	5	MabThera/Rituxan	Roche
Trastuzumab	Antineoplastic medicine (anticancer)	4	Herceptin	Roche
Total		18
*Data collected on 2 May 2017 Source: EMA

On 26 January 2017, EMA’s CHMP announced that it had recommended approval of Amgen’s adalimumab biosimilars Amgevita and Solymbic (ABP 501) [5]. The patents on the originator product AbbVie’s Humira (adalimumab) will only expire in Europe in June 2017 and in the US in November 2017 [6].

Since the last report entitled Biosimilars applications under review by EMA – December 2016 by GaBI Online, the number of pegfilgrastim applications has gone down from three to two; the CHMP previously announced that applications for marketing authorizations for the pegfilgrastim biosimilars Cavoley and Efgratin had been withdrawn [7]. The CHMP also gave positive opinionsfor the etanercept biosimilar Erelzi and the rituximab biosimilars Rixathon and Riximyo, all produced by Sandoz [8]. Stada Arzneimittel’s teriparatide biosimilar Movymia also gained European Commission approval on 11 January 2017 [4].

References
1.    GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. 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 May 19]. 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 May 19]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-rituximab-biosimilar-Truxima
4.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5.    GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Amgevita and Solymbic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Amgevita-and-Solymbic
6.    GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
7.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – December 2016 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-December-2016
8.    GaBI Online - Generics and Biosimilars Initiative. EMA approval for etanercept and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 19]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-etanercept-and-rituximab-biosimilars

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Source: EMA