Novartis’ Sandoz unit has gained approval in the European Union for its biosimilar version of Amgen’s Neupogen, for the treatment of neutropenia.
Sandoz’ version of filgrastim, a natural protein manufactured commercially by recombinant DNA technology, which stimulates production of white blood cells, is approved for the same range of indications as Neupogen. Neutropenia, is often associated with chemotherapy or bone marrow transplants, as well as advanced HIV infections, and is characterized by a lack of neutrophils – one of the most common types of white blood cells.
The Holzkirchen, Germany-based company says that its version offers patients “comparable quality, safety and efficacy combined with greater cost-effectiveness”. It added that the novel Sandoz filgrastim needlestick protection device “decreases the risks of injury and exposure to blood-born infection, thus contributing significantly to protecting health professionals”.
Chief executive Jeff George said that filgrastim helps patients receiving chemotherapy to increase their neutrophil counts, “meaning they can better avoid the risk of the serious life threatening infections that so often force clinicians to change their optimal therapeutic chemotherapy regimen, dose or schedule”.
This is the third biosimilar approval that Sandoz has secured, making it the only company with marketing authorization for more than one such medicine. In April 2006, European regulators cleared its version of the human growth hormone Omnitrope and in August 2007, the firm received approval for a biosimilar of Johnson & Johnson’s anaemia drug Epogen (epoetin alfa).
Nevertheless, Sandoz has to play catch-up with Teva in terms of filgrastim as the Israeli company and German partner Ratiopharm received European approval in September to start selling their version of Neupogen.
Alabama sues Sandoz over Medicaid over-pricing
Meantime, Sandoz finds itself at the centre of a lawsuit in Alabama amid claims that the firm inflated prices of its generics under the state’s Medicaid programme. The trial got underway at the end of last week and the state is demanding more than $28 million in penalties.
However, Tabor Novak, an attorney representing Sandoz told jurors that “this company by manufacturing generic drugs has done a service to the state by providing drugs at discount prices”. Sandoz is one of over 70 companies Alabama has sued for allegedly overcharging the Medicaid programme.
