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EMA recommends four new generics Posted 21/02/2020

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.

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

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