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 6 June 2018, the agency is currently reviewing 16 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 Adenuric (febuxostat), one for a generic version of Yargesa (miglustat), 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
Atazanavir	Antiviral for systemic use	1	Reyataz	Bristol-Myers Squibb
Buprenorphine	Opioid dependence	1	Suboxone	Indivior
Cabazitaxel	Antineoplastic medicine (anticancer)	1	Jevtana	Sanofi-Aventis
Deferiprone	beta-Thalassaemia (iron overload)	1	Ferriprox	Apotex
Doxorubicin	Antineoplastic medicine (anticancer)	1	Caelyx/Myocet	Janssen-Cilag/Teva
Febuxostat	Anti-gout	1	Adenuric	Menarini International
Gefitinib	Antineoplastic medicine (anticancer)	1	Iressa	AstraZeneca
Hydroxycarbamide	Antineoplastic medicine (anticancer)	1	Siklos	Addmedica
Ioflupane (¹²³I)	Diagnostic radiopharmaceutical	1	DaTSCAN	GE Healthcare
Lenalidomide	Immunosuppressant (multiple myeloma)	1	Revlimid	Celgene
Miglustat	Other alimentary tract and metabolism products (Gaucher Disease)	1	Zavesca	Actelion
Paclitaxel	Antineoplastic medicine (anticancer)	1	Abraxane	Celgene
Silodosin	Urological (prostatic hyperplasia)	1	Silodyx/Urorec	Recordati Ireland
Vigabatrin	Anti-epileptic	1	Sabril/Sabrilex	Lundbeck
Total		16
*Data collected on 5 July 2018. Source: EMA

First-time pan-European generics under review by EMA include one for a generic version of Glaxo’s pulmonary hypertension drug Volibris (ambrisentan), one for a generic of Indivior’s opioid treatment Suboxone (buprenorphine), one for 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 Janssen-Cilag/ Teva’s chemotherapy drug Caelyx/ Myocet (doxorubicin), one for a generic version of AstraZeneca’s lung cancer treatment Iressa (gefitinib), 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 multiple myeloma treatment Revlimid (lenalidomide), one for a generic version of Celgene’s chemotherapy drug Abraxane (paclitaxel), 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).

US generics company Alvogen announced in April 2018 that it had successfully concluded multiple registration procedures for its lenalidomide generic capsules [3].

Since the last report entitled ‘Generics applications under review by EMA – June 2018’ by GaBI Online, EMA has approved a generic version of Emcure Pharmaceuticals chemotherapy drug BiCNU (carmustine), a generic version of Swedish Orphan Biovitrum International’s treatment for hereditary tyrosinemia type 1 Orfadin (nitisinone), one for a generic version of Eli Lilly’s chemotherapy drug Alimta (pemetrexed), one for a generic version of Daiichi Sankyo’s angina treatment Efient (prasugrel), one for a generic version of UCB’s Parkinson’s disease treatment Leganto/Neupro (rotigotine) and one for a generic version of Janssen Pharmaceutica’s potent opioid anaesthetic Sufenta (sufentanil).

The European Commission (EC) announced on 28 May 2018 a proposal to refine the intellectual property rules in Europe and thereby remove a major competitive disadvantage for EU manufacturers. The EC is proposing an ‘export manufacturing waiver’ to Supplementary Protection Certificates (SPCs) to allow EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed. Such waivers, says the EC, ‘will support Europe’s pioneering role in pharmaceutical research and development’ [4].

Generics applications under review by EMA – January 2018

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 24]. 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 2018 Aug 24] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU
3. GaBI Online - Generics and Biosimilars Initiative. Alvogen receives European approval for generic lenalidomide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 24] Available from: www.gabionline.net/Generics/News/Alvogen-receives-European-approval-for-generic-lenalidomide
4. GaBI Online - Generics and Biosimilars Initiative. EC proposes waiver of SPCs to allow manufacturing of generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 24] Available from: www.gabionline.net/Policies-Legislation/EC-proposes-waiver-of-SPCs-to-allow-manufacturing-of-generics-and-biosimilars

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Source: EMA