Products

Date: 2018-07-26

Type of information: Positive opinion for the granting of a Market Authorisation in the EU

Product name: Binocrit®

Compound: biosimilar epoetin alfa

Therapeutic area: Kidney diseases - Renal diseases

Action mechanism:

• erythropoiesis-stimulating agent/biosimilar. This biosimilar product is a erythropoiesis-stimulating agent.

Company: Sandoz (Switzerland)

Disease:

• anemia associated with chronic kidney disease
• anaemia and reduction of transfusion requirements in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy)
• predonation programme to increase the yield of autologous blood
• non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions
• symptomatic anaemia in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS)

Latest news:

• • On 26 July 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Binocrit®. The committee adopted a new indication as follows:
• “Binocrit® is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ?10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/ml).” The full indications for Binocrit® will be as follows:
• -Binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
• • in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis
• • in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients -Binocrit® is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.
• -Binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood. Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dl [6.2 to 8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). -Binocrit® is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl or 6.2 to 8.1 mmol/l) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1,800 ml). -Binocrit® is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ? 10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/ml).
• • On  April 8, 2016, Sandoz announced that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (s.c.) route of administration in Binocrit’s® (epoetin alfa) nephrology indication.
• • On February 25, 2016, the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a type II variation for the addition of a subcutaneous  route of administration in Binocrit’s® (epoetin alfa) nephrology indication. The CHMP positive opinion was based on data from the SENSE clinical study an open label, single arm, multicenter study to evaluate the safety and immunogenicity of HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis patients.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2016-04-08

Favourable opinion UE: 2018-07-26

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes