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.

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].

Related articles
Biosimilars applications under review by EMA – January 2020

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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