EMA recommends four new generics

Genéricos/Novedades | Posted 21/02/2020 post-comment0 Post your comment

At the Committee for Medicinal Products for Human Use’s (CHMP) January 2020 meeting, the Committee recommended four new generics, and one new biosimilar, for approval.

80 MD002386

The European Medicines Agency’s (EMA) latest CHMP meeting took place 27−30 January 2020.

At the meeting, the CHMP recommended a total of 15 medicines for approval, including four generic medicines:
Azacitidine betapharm (azacytidine), from betapharm Arzneimittel GmbH, for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia
Azacitidine Mylan (azacitidine), from Mylan, for the same indications
Arsenic trioxide Mylan (arsenic trioxide), also from Mylan, for the treatment of acute promyelocytic leukaemia
Cinacalcet Accord Pharma (cinacalcet), from Cinacalcet, for the treatment of secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism

The Committee also recommended one new biosimilar:
Ruxience (rituximab), from Pfizer, for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and Pemphigus vulgaris

All of the recommended drugs are awaiting European Commission approval for launch.

Related articles
3983D EMA approval for rituximab biosimilar Ruxience
http://www.gabionline.net/Biosimilars/News/EMA-approval-for-rituximab-biosimilar-Ruxience

3979C Generics applications under review by EMA – January 2020
http://www.gabionline.net/Generics/General/Generics-applications-under-review-by-EMA-January-2020
The European Medicines Agency’s (EMA) latest CHMP meeting took place 27−30 January 2020.

At the meeting, the CHMP recommended a total of 15 medicines for approval, including four generic medicines:
Azacitidine betapharm (azacytidine), from betapharm Arzneimittel GmbH, for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia
Azacitidine Mylan (azacitidine), from Mylan, for the same indications
Arsenic trioxide Mylan (arsenic trioxide), also from Mylan, for the treatment of acute promyelocytic leukaemia
Cinacalcet Accord Pharma (cinacalcet), from Cinacalcet, for the treatment of secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism

The Committee also recommended one new biosimilar:
Ruxience (rituximab), from Pfizer, for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and Pemphigus vulgaris

All of the recommended drugs are awaiting European Commission approval for launch.

Related articles
EMA approval for rituximab biosimilar Ruxience

Generics applications under review by EMA – January 2020

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Pfizer and Merck COVID-19 antiviral progress
26 AA011066
Genéricos/Novedades Posted 12/11/2021
Sun Pharma and Dr Reddy’s generics progress in EU and US
Diabetes V14K06
Genéricos/Novedades Posted 05/11/2021
Oncology generics launched by MSN Labs and Natco Pharma
84 MD002440
Genéricos/Novedades Posted 29/10/2021
Sandoz launches ferumoxytol and pemetrexed generics
88 MD002468
Genéricos/Novedades Posted 03/09/2021
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010