Novartis has announced its generics unit has received approval from the European Commission for its biosimilar epoetin alfa drug, which controls the formation of red blood cells.
The decision to grant approval to its Sandoz arm follows a ruling from the European Medicines Agency’s Committee on Medicinal Products for Human Use, which reviews medicines scientifically for the Commission.
The approval allows the biosimilar epoetin alfa to be used in treating patients with renal anaemia, as well as those receiving chemotherapy.
Sandoz predicts these products will play an even greater role in the company’s strategy over the coming years, as more biopharmaceuticals lose their patent protection.
More than 250,000 patients across Europe are believed to be treated with epoetin alfa, which is marketed under various different brand names.
Annual sales worldwide are estimated to be worth more than £3.5bn, of which Europe accounts for around £300m.
Sandoz CEO Andreas Rummelt said: “We are pleased that the European Commission has taken the final step in approving our biosimilar epoetin alfa for marketing in Europe, and we will quickly bring this product to market for the patients and physicians who need it.
“We are committed to continue making high-quality and cost-effective biosimilars available, and have several projects in our pipeline.”
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