Bortezomib Fresenius Kabi

bortezomib

Opinion

On 19 September 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Bortezomib Fresenius Kabi, intended for the treatment of multiple myeloma and mantle cell lymphoma. The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH.

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

Bortezomib Fresenius Kabi is a generic of Velcade, which has been authorised in the EU since 26 April 2004. Since Bortezomib Fresenius Kabi is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Velcade was not required. 

The full indication is:

“Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is 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 in combination with melphalan and prednisone is 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 in combination with dexamethasone, or with dexamethasone and thalidomide, is 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 in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is 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 Fresenius Kabi be prescribed by physicians qualified and experienced in the use of chemotherapeutic agents.

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

Key facts

Name
Bortezomib Fresenius Kabi
Agency product number
EMEA/H/C/005074
International non-proprietary name (INN) or common name
  • bortezomib
Active substance
  • bortezomib
Therapeutic area
Multiple Myeloma
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Date opinion adopted
19/09/2019
Company name
Fresenius Kabi Deutschland GmbH
Status
Positive
Application type
Initial authorisation

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