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 the 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 2020, the agency is currently reviewing 28 applications for marketing approval in the EU for generics.

The applications include one for a generic version of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole), one for a generic of arthritis drug Azasan/Imuran/Imurel (azathioprine), one for a generic version of AstraZeneca’s chronic obstructive pulmonary disease treatment Symbicort (budesonide/formoterol), one for Amgen’s hyperparathyroidism treatment Mimpara/Sensipar (cinacalcet), one for a generic version of ioflupane (123I), a radiopharmaceutical for the diagnosis of Parkinson’s disease and other related diseases and dementia, one for a generic version of Celgene’s Revlimid (lenalidomide) 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)
Abiraterone	Endocrine therapy	1	Zytiga	Janssen-Cilag
Apixaban	Antithrombotic medicine (anti-blood clot)	1	Eliquis	Bristol-Myers Squibb
Aripiprazole	Psycoleptic (schizophrenia)	1	Abilify	Otsuka Pharmaceutical
Arsenic trioxide	Antineoplastic medicine (anticancer)	2	Trisenox	Teva Pharmaceutical Industries
Azacitidine	Antineoplastic medicines (anticancer)	2	Vidaza	Celgene (Pharmion Corporation)
Azathioprine	Immunosuppressant	1	Azasan/Imuran/Imurel	–
Budesonide/ formoterol	Obstructive airway diseases	1	Symbicort	AstraZeneca
Cabazitaxel	Antineoplastic medicines (anticancer)	1	Jevtana	sanofi-aventis
Caffeine citrate	Psychoanaleptics (breathing problems)	1	Cafcit/Peyona (previously Nymusa)	Boehringer Ingelheim/Chiesi Farmaceutici
Cinacalcet	Calcium homeostasis	1	Mimpara/Sensipar	Amgen
Dasatinib	Antineoplastic medicines (anticancer)	2	Sprycel	Bristol-Myers Squibb
Doxorubicin	Antineoplastic medicines (anticancer)	2	Caelyx/Myocet	Janssen-Cilag/Teva Pharmaceutical Industries
Erlotinib	Antineoplastic medicines (anticancer)	1	Tarceva	Roche
Fampridine	Other nervous system medicines (multiple sclerosis)	1	Fampyra	Biogen
Fingolimod	Immunosuppressant (multiple sclerosis)	2	Gilenya	Novartis
Glucagon	Pancreatic hormones (diabetes)	1	Baqsimi	Eli Lilly
Ioflupane (123I)	Diagnostic radiopharmaceuticals	1	DaTSCAN	GE Healthcare
Lenalidomide	Immunosuppressant (multiple myeloma)	1	Revlimid	Celgene
Melphalan	Antineoplastic medicines (anticancer)	1	Alkeran	ApoPharma
Methylthioninium chloride	Diagnostic medicine	1	Proveblue	Provepharm SAS
Rivaroxaban	Antithrombotic medicines (blood thinner)	1	Xarelto	Bayer
Sunitinib	Antithrombotic medicines (renal cell carcinoma)	1	Sutent	Pfizer
Tigecycline	Antibacterials for systemic use	1	Tygacil	Pfizer
Total		28
*Data collected on 31 January 2020 Source: EMA

First-time pan-European generics under review by EMA include one for a generic version of Janssen-Cilag’s prostate cancer drug Zytiga (abiraterone), one for a generic of Bristol-Myers Squibb’s blood clot preventer Eliquis (apixaban), two for generics of Teva’s leukaemia drug Trisenox (arsenic trioxide), two for generics of Celgene’s treatment for myelodysplastic syndrome Vidaza (azacitidine), one for a generic version of sanofi-aventis' prostate cancer drug Jevtana (cabazitaxel), one for a generic version of Boehringer Ingelheim/Chiesi Farmaceutici’s treatment for apnea (breathing problems) Cafcit/Peyona (caffeine citrate), two for generics of Bristol-Myers Squibb’s leukaemia drug Sprycel (dasatinib), two for generic versions 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 multiple sclerosis drug one for a generic version of Biogen’s multiple sclerosis drug Fampyra (fampridine), two for a generic version of multiple sclerosis drug Gilenya (fingolimod) from Novartis, one for a generic version of diabetes treatment Baqsimi (glucagon), one for a generic version of chemotherapy drug Alkeran (melphalan), one for a generic of Bayer’s anti-blood clotting medicine Xarelto (rivaroxaban) and one for a generic of Pfizer’s cancer treatment Sutent (sunitinib).

Since the last report entitled Generics applications under review by EMA – July 2019 by GaBI Online, EMA has approved one generic version of Celgene’s myelodysplastic syndrome Vidaza (azacytidine) from Accord, four generics of Janssen-Cilag’s multiple myeloma treatment Velcade (bortezomib), one for Bristol-Myers Squibb/Sanofi’s blood-clot treatment DuoPlavin (clopidogrel/acetylsalicylic acid), two generics of iron chelator Exjade (deferasirox), one generic version of Orion’s psycholeptic Dexdor (dexmedetomidine) and one for a generic version of ProvePharma’s methaemoglobinaemia treatment Proveblue (methylthioninium chloride).

EMA’s CHMP approved Arsenic trioxide Accord for the treatment of leukaemia, Bortezomib Fresenius Kabi for the treatment of multiple myeloma and Orphelia Pharma’s Ivozall, which is a generic version of Genzyme’s Evoltra (clofarabine) on 20 September 2019 [3]. Evoltra is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), which is a cancer of the lymphocytes (a type of white blood cell).

In November 2019, EMA’s CHMP also adopted a positive opinion, recommending the granting of a marketing authorization for a new generic for the treatment of clopidogrel/acetylsalicylic acid produced by generics giant Mylan [4].

Generics applications under review by EMA – July 2019

References
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. 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 2020 Feb 7] Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU
3. GaBI Online - Generics and Biosimilars Initiative. EMA approves leukaemia and multiple myeloma generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Generics/News/EMA-approves-leukaemia-and-multiple-myeloma-generics
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for two new generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Generics/News/EMA-recommends-approval-for-two-new-generics

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Source: EMA