Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body . 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 .
Generics applications under review by EMA – July 2021
Generics/General | Posted 23/07/2021 0 Post your comment
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 9 July 2021, the agency is currently reviewing 26 applications for marketing approval in the EU for generics.
The applications include five for anti-neoplastic (anti-cancer) medicines (dasatinib, doxorubicin and imatinib); two for endocrine therapy leuprorelin; one for psycholeptic risperidone; one for anti-thrombic medicine rivaroxaban 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|
|Dabigatran||Anti-thrombotic medicine||1||Pradaxa||Boehringer Ingelheim|
|Dasatinib||Anti-neoplastic medicine (anti-cancer)||2||Sprycel||Bristol-Myers Squibb|
|Dimethyl fumarate||Immunosuppressant (multiple sclerosis)||2||Tecfidera||Biogen|
|Doxorubicin||Anti-neoplastic medicine (anti-cancer)||2||Caelyx/Myocet||Janssen-Cilag/ Teva Pharmaceutical Industries|
|Ertapenem||Antibacterial||1||Invanz||Merck Sharp and Dohme|
|Ganirelix||Pituitary and hypothalamic hormones and analogues||1||Orgalutran||Organon|
|Imatinib||Anti-neoplastic medicine (anti-cancer)||1||Glivec||Novartis|
|Merck Sharp and Dohme|
|Pirfenidone||Immunosuppressant (Idiopathic Pulmonary Fibrosis)||1||Esbriet||Roche|
|Sapropterin||Metabolism products (HPA)||1||Kuvan||BioMarin International|
|Sitagliptin||Diabetes||2||Januvia/Ristaben/ Tesavel/Xelevia||Merck Sharp and Dohme|
|Sugammadex||Therapeutic medicine (reversal of anaesthesia)||2||Bridion||Merck Sharp and Dohme|
|Thalidomide||Immunosuppressant (multiple myeloma)||1||-||-|
*Data collected on 23 July 2021.
HPA: hyperphenylalaninemia; LEMS: Lambert-Eaton Myasthenic Syndrome
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; 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 anti-coagulant Pradaxa (dabigatran); two for generic versions of multiple sclerosis treatment Tecfidera (dimethyl fumarate); one for a generic version of antibacterial Invanz (ertapenem); one for a generic version of hormone treatment Orgalutran (ganirelix); one for a generic version of Idiopathic Pulmonary Fibrosis treatment Esbriet (pirfenidone); one for a generic version of hyperphenylalaninemia treatment Kuvan (sapropterin); one for generic version of urological drug Viagra/Revatio (sildenafil); one for a generic version of anaesthesia reversal medicine Bridion (sugammadex) and five for generic versions of diabetes medicines (sitagliptin, metformin/ sitagliptin and vildagliptin/ metformin).
Since the last report entitled Generics applications under review by EMA – January 2021 by GaBI Online, EMA has approved one generic version of endocrine therapy abiraterone; one generic version of psycholeptic aripiprazole; one generic version of corticosteroid dexamethasone for the treatment of COVID-19 patients; one generic version of icatibant for the treatment of hereditary angioedema (a disorder that causes severe swelling); one for a diagnostic medicine ioflupane (123I); one generic of immunosuppressant fingolimod; and one for anti-neoplastic (anti-cancer) medicine thiotepa.
Generics of anticancer medications abiraterone and thiotepa were approved by the EMA’s CHMP in January and February 2021 .
The EMA’s CHMP also recommended approval of abiraterone and ioflupane (123I) generics at its April 2021 meeting .
Generics applications under review by EMA – January 2021
LATIN AMERICAN FORUM
The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.
View this week’s headline article: ¿Qué conduce a las percepciones negativas de los biosimilares?
Browse the news in the Latin American Forum!
LATIN AMERICAN FORUM
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
Vea el artículo principal de esta semana: ¿Qué conduce a las percepciones negativas de los biosimilares?
Explore las noticias en el Foro Latinoamericano!
1. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 23]. 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 2021 Jul 23]. Available from: www.gabionline.net/Reports/Registration-procedures-for-generic-drugs-in-the-EU
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