Image by Andre E.X. Brown
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 biosimilars of the low-molecular-weight heparin enoxaparin.
Both of the agents, Inhixa and Thorinane, are intended to prevent and treat thrombosis-related disorders in adults.
The CHMP’s recommendations will be reviewed by the European Commission.
If the recommendations are formally adopted, Inhixa and Thorinane will be approved for use in the European Union as well as Norway, Liechtenstein, and Iceland.
Both Inhixa and Thorinane are indicated for:
- Prophylaxis of venous thromboembolism (VTE), particularly in patients undergoing orthopedic, general, or oncological surgery.
- VTE prophylaxis in patients bedridden due to acute illnesses, including acute heart failure, acute respiratory failure, severe infections, and exacerbation of rheumatic diseases causing immobilization of the patient (applies to strengths of 40 mg/0.4 mL).
- Treatment of deep vein thrombosis, complicated or uncomplicated by pulmonary embolism.
- Treatment of unstable angina and non-Q wave myocardial infarction, in combination with acetylsalicylic acid.
- Treatment of acute ST segment elevation myocardial infarction, including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
- VTE prevention in the extracorporeal circulation during hemodialysis.
If approved, Inhixa will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.
And Thorinane will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.
Inhixa is being developed by Techdow Europe AB, and Thorinane is being developed by Pharmathen S.A.
