Date: 2018-07-26
Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Abseamed®
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: Medice Arzneimittel Pütter GmbH & Co (Germany)
Disease:
- *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
*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 (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)
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 Abseamed®. The committee adopted a new indication as follows: Abseamed® 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).
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: 2007-08-28
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
