EMA Recommends Granting a Marketing Authorisation for Generic Bortezomib

Bortezomib Hospira and Bortezomib SUN are intended for the treatment of multiple myeloma and mantle cell lymphoma

On 26 May 2016, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal products Bortezomib Hospira and Bortezomib SUN, intended for the treatment of multiple myeloma and mantle cell lymphoma. 

The applicants for these medicinal products are Hospira UK Limited and SUN Pharmaceutical Industries (Europe) B.V.

Bortezomib Hospira and Bortezomib SUN will be available as a 3.5 mg powder for solution for injection. The active substance of Bortezomib Hospira and Bortezomib SUN is bortezomib, an antineoplastic agent (ATC code: L01XX32). Bortezomib is a cytotoxic chemical entity that inhibits the proteolytic activity of the proteasome, a proteolytic complex that is involved in the breakdown of cellular proteins.

Bortezomib Hospira and Bortezomib SUN are generic of Velcade, which has been authorised in the EU since 26 April 2004. Studies have demonstrated the satisfactory quality of Bortezomib Hospira and Bortezomib SUN. Since Bortezomib Hospira and Bortezomib SUN are administered intravenously and are 100% bioavailable, a bioequivalence study versus the reference product Velcade was not required.

The full indication is:

Bortezomib Hospira and Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone are indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.

Bortezomib Hospira and Bortezomib SUN in combination with melphalan and prednisone are indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib Hospira and Bortezomib SUN in combination with dexamethasone, or with dexamethasone and thalidomide, are indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib Hospira and Bortezomib SUN in combination with rituximab, cyclophosphamide, doxorubicin and prednisone are indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

It is proposed that Bortezomib Hospira and Bortezomib SUN must be initiated and administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents. Bortezomib Hospira and Bortezomib SUN must be reconstituted by a healthcare professional. 

Detailed recommendations for the use of these products 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.