Generics applications under review by EMA

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 7 January 2019, the agency is currently reviewing 19 applications for marketing approval in the EU for generics. The applications include one for a generic version of Reyataz (atazanavir), one for a generic version of Janssen-Cilag’s multiple myeloma treatment Velcade (Bortezomib), one for Bristol-Myers Squibb/Sanofi’s blood-clot treatment DuoPlavin (clopidogrel/ acetylsalicylic acid), one for a generic version of Adenuric (febuxostat) and one for a generic version of Pfizer’s bacterial infection treatment Tygacil (tigecycline), for which there are already generics 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)
Ambrisentan	Antihypertensive	2	Volibris	Glaxo
Arsenic trioxide	Antineoplastic medicines (anticancer)	1	Trisenox	Teva Pharmaceutical Industries
Atazanavir	Antiviral for systemic use	1	Reyataz	Bristol-Myers Squibb
Bortezomib	Antineoplastic medicines (anticancer)	1	Velcade	Janssen-Cilag
Cabazitaxel	Antineoplastic medicines (anticancer)	1	Jevtana	sanofi-aventis
Clofarabine	Antineoplastic medicines (anticancer)	1	Evoltra	Genzyme
Clopidogrel/ acetylsalicylic acid	Antithrombotic medicines (anti-blood clot)	1	DuoPlavin	Bristol-Myers Squibb/ Sanofi
Deferasirox	Other therapeutic medicines (iron chelator)	2	Exjade	Novartis
Dexmedetomidine	Psycholeptics (sedative)	1	Dexdor	Orion
Doxorubicin	Antineoplastic medicine (anticancer)	1	Caelyx/Myocet	Janssen-Cilag/ Teva Pharmaceutical Industries
Erlotinib	Antineoplastic medicine (anticancer)	1	Tarceva	Roche
Febuxostat	Anti-gout	1	Adenuric	Menarini International
Hydroxycarbamide	Antineoplastic medicine (anticancer)	1	Siklos	Addmedica
Ioflupane (¹²³I)	Diagnostic radiopharmaceutical	1	DaTSCAN	GE Healthcare
Paclitaxel	Antineoplastic medicine (anticancer)	1	Abraxane	Celgene
Posaconazole	Antimycotic for systemic use (antifungal)	1	Noxafil	MSD
Tigecycline	Antibacterials for systemic use	1	Tygacil	Pfizer
Total		19
*Data collected on 1 February 2019. Source: EMA

First-time pan-European generics under review by EMA include two for a generic version of Glaxo’s pulmonary hypertension drug Volibris (ambrisentan), one for a generic of Teva’s leukaemia drug Trisenox (arsenic trioxide), one for a generic version of Janssen-Cilag’s prostate cancer drug Jevtana (cabazitaxel), one for a generic version of leukaemia medicine Evoltra (clofarabine), two for generic versions of iron chelator Exjade (deferasirox) from Novartis, one for a generic version of Orion’s psycholeptic Dexdor (dexmedetomidine), one for a generic version of Janssen-Cilag/ Teva’s chemotherapy drug Caelyx/Myocet (doxorubicin), one for a generic version of Roche’s Tarceva (erlotinib), one for a generic version of Addmedica’s leukaemia and cervical cancer drug Siklos (hydroxycarbamide), one for a generic version of GE Healthcare’s neuroimaging drug DaTSCAN (ioflupane (¹²³l), one for a generic version of Celgene’s chemotherapy drug Abraxane (paclitaxel), and one for a generic version of MSD’s fungus treatment Noxafil (posaconazole).

Since the last report entitled Generics applications under review by EMA – June 2018 by GaBI Online, EMA has approved a generic version of Indivior’s opioid treatment Suboxone (buprenorphine), a generic version of prostate cancer treatment Jevtana (cabazitaxel) from sanofi-aventis, one for a generic version of Apotex’s iron overload in Thalassaemia treatment Ferriprox (deferiprone), one for a generic version of AstraZeneca’s lung cancer treatment Iressa (gefitinib), one for a generic version of Celgene’s multiple myeloma treatment Revlimid (lenalidomide), one for a generic version of Yargesa (miglustat), one for a generic version of Recordati Ireland’s treatment for enlarged prostate Silodyx/Urorec (silodosin), and one for a generic of Lundbeck’s epilepsy drug Sabril/Sabrilex (vigabatrin).

In light of recent increases in the price of generics, the UK’s National Audit Office (NAO) carried out an investigation into the causes of price increases during 2017. NAO found that the prices of some generics increased more than tenfold. For example, at its peak, antipsychotic drug quetiapine (100 mg tablets) cost GBP 113.10, which is 70 times higher than its previous set price of GBP 1.59 [3].

Generics applications under review by EMA – June 2018

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1]. 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 2019 Feb 1] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU
3. GaBI Online - Generics and Biosimilars Initiative. UK investigates price increases for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 1] Available from: www.gabionline.net/Generics/General/UK-investigates-price-increases-for-generics

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Source: EMA