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EMA Recommends Granting Marketing Authorisation for Generic Azacitidine

Azacitidine betapharm and Azacitidine Mylan are generic of Vidaza, which has been authorised in the EU since 2008
16 Mar 2020
Anticancer agents & Biologic therapy;  Haematologic malignancies

On 30 January 2020, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal products Azacitidine betapharm and Azacitidine Mylan, intended for the treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML).

The applicant for Azacitidine betapharm is betapharm Arzneimittel GmbH and the applicant for Azacitidine Mylan is Mylan Ireland Limited.

Azacitidine betapharm and Azacitidine Mylan will be available as powder for suspension for injection (25 mg/ml). The active substance of Azacitidine betapharm and Azacitidine Mylan is azacitidine, a pyrimidine analogue (ATC code: L01BC07) which exerts its antineoplastic effects by multiple mechanisms, including cytotoxicity on cells in the bone marrow and hypomethylation of DNA.

Azacitidine betapharm and Azacitidine Mylan are generic of Vidaza, which has been authorised in the EU since 17 December 2008. Studies have demonstrated the satisfactory quality of Azacitidine betapharm and Azacitidine Mylan. Since Azacitidine betapharm is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Vidaza was not required.

Azacitidine betapharm and Azacitidine Mylan are indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with:

  • intermediate-2 and high-risk MDS according to the International Prognostic Scoring System,
  • CMML with 10% to 29% marrow blasts without myeloproliferative disorder,
  • AML with 20% to 30% blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification,
  • AML with >30% marrow blasts according to the WHO classification.

It is proposed that Azacitidine betapharm and Azacitidine Mylan be prescribed by physicians experienced in the use of chemotherapeutic agents.

Detailed recommendations for the use of these products will be described in the summary of products characteristics, which will be published in the European public assessment reports and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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