Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
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 January 2022, the agency is currently reviewing 35 applications for marketing approval in the EU for generics.
The applications include four for anti-neoplastic (anticancer) medicines (masitinib, doxorubicin); one for endocrine therapy leuprorelin; one for Gaucher disease treatment Yargesa (miglustat), one for a generic version of Alimta (pemetrexed), one for a generic version of diabetes medicine Efficib/Janumet/Velmetia (sitagliptin/metformin and one for multiple myeloma treatment thalidomide. There are already generics of these drugs approved by EMA for all EU countries, see Table 1.
| Table 1: Generics under review by EMA*
|
| Common name
|
Therapeutic area
|
Number of applications
|
EMA-approved originator(s)
|
Originator company(ies)
|
| Amifampridine
|
Potassium channel blocker (LEMS)
|
1
|
Firdapse (previously Zenas)
|
SERB
|
| Betaine
|
Alimentary tract and metabolism (homocystinuria)
|
1
|
Cystadane
|
Recordati Rare Diseases
|
| Budesonide
|
Anti-diarrheal, intestinal anti‑inflammatory/ anti‑infective agent
|
1
|
Jorveza
|
Dr Falk Pharma
|
| Dabigatran
|
Anti-thrombotic medicine
|
1
|
Pradaxa
|
Boehringer Ingelheim
|
| Dasatinib
|
Anti-neoplastic medicine (anticancer)
|
2
|
Sprycel
|
Bristol-Myers Squibb
|
| Dimethyl fumarate
|
Immunosuppressant (multiple sclerosis)
|
6
|
Tecfidera
|
Biogen
|
| Doxorubicin
|
Anti-neoplastic medicine (anticancer)
|
2
|
Caelyx/Myocet
|
Janssen-Cilag/ Teva Pharmaceutical Industries
|
| Ertapenem
|
Anti‑bacterial
|
1
|
Invanz
|
Merck Sharp and Dohme
|
| Ganirelix
|
Pituitary and hypothalamic hormones and analogues
|
1
|
Orgalutran
|
Organon
|
| Leuprorelin
|
Endocrine therapy
|
1
|
–
|
–
|
| Miglustat
|
Other alimentary tract and metabolism products (Gaucher disease)
|
1
|
Zavesca
|
Actelion
|
| Octreotide acetate
|
Pituitary and hypothalamic hormones and analogues
|
1
|
–
|
–
|
| Pemetrexed
|
Antineoplastic medicine (anticancer)
|
1
|
Alimta
|
Eli Lilly
|
| Pirfenidone
|
Immunosuppressant (Idiopathic Pulmonary Fibrosis)
|
2
|
Esbriet
|
Roche
|
| Plerixafor
|
Immunostimulant (multiple myeloma/ haematopoietic stem cell transplantation/ lymphoma)
|
1
|
Mozobil
|
Genzyme
|
| Sirolimus
|
Immunosuppressant (graft rejection/ kidney transplantation)
|
1
|
Rapamune
|
Pfizer
|
| Sitagliptin
|
Diabetes
|
1
|
Januvia/Ristaben/
Tesavel/Xelevia
|
Merck Sharp and Dohme
|
| Sitagliptin/ metaformin
|
Diabetes
|
1
|
Efficib/Janumet/ Ristfor/Velmetia
|
Merck Sharp and Dohme
|
| Sorafenib
|
Anti‑neoplastic medicine (hepatocellular and renal cell carcinoma)
|
1
|
Nexavar
|
Bayer
|
| Spironolactone
|
Diuretic (heart failure)
|
1
|
Aldactone
|
Pfizer
|
| Sugammadex
|
Therapeutic medicine (reversal of anaesthesia)
|
2
|
Bridion
|
Merck Sharp and Dohme
|
| Teriflunomide
|
Immunosuppressant (multiple sclerosis)
|
2
|
Aubagio
|
sanofi-aventis
|
| Thalidomide
|
Immunosuppressant (multiple myeloma)
|
1
|
-
|
-
|
| Tolvaptan
|
Diuretic (low blood sodium levels)
|
1
|
Jinarc/Samsca
|
Otsuka Pharmaceutical
|
| Vildagliptin/ metformin
|
Diabetes
|
1
|
Eucreas/Icandra/ Zomarist
|
Novartis
|
| Total
|
|
35
|
|
|
*Data collected on 18 January 2022.
HPA: hyperphenylalaninaemia; LEMS: Lambert-Eaton Myasthenic Syndrome.
Source: EMA.
|
First-time pan-European generics under review by EMA include one for a generic version of Firdapse (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS); one for a generic version of Cystadane (betaine) for the treatment of Homocystinuria (a rare inherited disorder of the amino acid methionine); one for a generic version of Crohn's disease treatment Jorveza (budesonide); one for a generic version of anti-coagulant Pradaxa (dabigatran); six for generic versions of multiple sclerosis treatment Tecfidera (dimethyl fumarate); one for a generic version of antibacterial Invanz (ertapenem); two for generic versions of hormone treatments Orgalutran (ganirelix) and octreotide acetate; two for generic versions of Idiopathic Pulmonary Fibrosis treatment Esbriet (pirfenidone); one for a generic version of multiple myeloma treatment Mozobil (plerixafor); one for a generic version of Rapamune (sirolimus), which is used for the prophylaxis of organ rejection; one for a generic version of renal cell carcinoma treatment Nexavar (sorafenib); one for a generic version of heart failure treatment Aldactone (spironolactone); two for generic versions of anaesthesia reversal medicine Bridion (sugammadex); two for generic versions of multiple sclerosis treatment Aubagio (teriflunomide); one for a generic version of diuretic Jinarc/Samsca (tolvaptan) and two for generic versions of diabetes medicines (sitagliptin and vildagliptin/ metformin).
Since the last report entitled Generics applications under review by EMA – July 2021 by GaBI Online, EMA has approved one generic version of anti-neoplastic (anticancer) medicine imatinib; two for generic versions of diabetes medicines metformin/ sitagliptin; one generic version of psycholeptic risperidone; one generic version of anti-thrombic medicine rivaroxaban; one generic version of hyperphenylalaninaemia treatment sapropterin; one generic version of urological drug sildenafil and one generic version of diabetes medicine sitagliptin/metformin.
Related articles
Biosimilars applications under review by EMA – January 2022
Generics applications under review by EMA – July 2021
References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/guidelines/EU-guidelines-for-generics
2. GaBI Online - Generics and Biosimilars Initiative. Registration procedures for generic drugs in the EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jan 28]. Available from: www.gabionline.net/reports/Registration-procedures-for-generic-drugs-in-the-EU
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