EMA Recommends Granting a Marketing Authorisation for Generic Abiraterone for the Treatment of Metastatic Prostate Cancer

On 25 February 2021, 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 product Abiraterone Accord, intended for the treatment of metastatic prostate cancer.

The applicant for this medicinal product is Accord Healthcare S.L.U.

Abiraterone Accord will be available as 250 mg tablet and 500 mg film-coated tablet. The active substance of Abiraterone Accord is abiraterone (as abiraterone acetate), a hormone antagonist (ATC code: L02BX03) that inhibits the production of androgens in the testes, adrenal glands and prostatic tumour tissues.

Abiraterone Accord is a generic of Zytiga, which has been authorised in the EU since 5 September 2011. Studies have demonstrated the satisfactory quality of Abiraterone Accord, and its bioequivalence to the reference product Zytiga.

The full indication for Abiraterone Accord with prednisone or prednisolone is for:

  • the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer in adult men in combination with androgen deprivation therapy (ADT)
  • the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated
  • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Abiraterone Accord should be prescribed by an appropriate healthcare professional.

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

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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