Novartis’ generics unit Sandoz has pulled off a coup by becoming the first company to get the go-ahead in Europe to develop a generic version of the anaemia drug epoetin alfa.
The Swiss firm confirmed that Sandoz has received European Commission approval for its biosimilar epoetin alfa, a copy of Johnson & Johnson’s Eprex, having received a positive opinion in June from the European Medicines Agency's Committee on Medicinal Products for Human Use. The approval means the drug can be used to treat patients with renal anaemia as well as those receiving chemotherapy.
The market is a sizeable one and Novartis noted that more than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, notably Eprex and Amgen’s Epogen. Worldwide annual sales are estimated at more than $7 billion, $600 million of which comes from Europe.
Sandoz chief executive Andreas Rummelt said that “we will quickly bring this product to market for the patients and physicians who need it," adding that “we are committed to continue making high-quality and cost-effective biosimilars available and have several projects in our pipeline." This is the second time the EC has granted approval to Sandoz for a biosimilar; indeed it was the first company to obtain European approval for such a medicine, the human growth hormone Omnitrope, a copycat version of Pfizer's Genotropin (somatropin).
Another two Eprex biosimilars were recommended for approval in June by the CHMP, one from Hexal (also owned by Novartis) and the other developed by Medice Arzneimittel Puetter.
NICE recommends Xolair
Meantime, Novartis noted that it has received a recommendation from the UK’s National Institute for Health and Clinical Excellence for the use of Xolair (omalizumab) on the National Health Service as an add-on therapy for patients over 12 who have had two or more serious asthma attacks requiring hospital treatment in the previous year.
The drug was also recommended for patients who suffered three or more severe exacerbations within the previous year, at least one of which required hospitalisation, as well as for those requiring special monitoring in an accident and emergency unit.