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NEW YORK — Generic drug maker Sandoz has relaunched a website to promote its biosimilars business.
The global website aims to educate the public about biosimilars, which are knock-off versions of biotech drugs. The Patient Protection and Affordable Care Act of 2010 included a provision creating an abbreviated regulatory approval pathway for the drugs similar to the one created for generic pharmaceutical drugs by the Hatch-Waxman Act of 1984. For the moment, companies looking to market a biosimilar version of a branded biologic in the United States must use the traditional approval pathway, including conducting three phases of clinical trial programs. A recent report by pharmacy benefit manager Express Scripts found that if just a handful of biosimilars were to enter the market, patients and payers in the United States stood to save up to $250 billion between 2014 and 2024. Biotech drugs can often be extremely expensive, costing patients hundreds of thousands of dollars per year.
The site includes information about biosimilars and a list of biosimilars currently undergoing clinical trials, including versions of Genentech and Biogen Idec's autoimmune disorder and cancer treatment Rituxan (rituximab); Amgen's drug for increasing white blood cell counts in patients undergoing chemotherapy, Neupogen (filgrastim) and Neulasta (pegfilgrastim); and Amgen and Pfizer's autoimmune disorder treatment Enbrel (etanercept).
Currently, Sandoz, the generics division of Swiss drug maker Novartis, is one of a handful of companies that manufactures biosimilars, mainly for the European market. While the new law created a legal pathway, the Food and Drug Administration is still working on how to regulate them. The other principal companies that make biosimilars for the European market are U.S.-based Hospira and Israel-based Teva Pharmaceutical Industries. In addition, Sandoz makes a biosimilar version of Pfizer's growth-hormone treatment Genotropin (somatropin [rDNA origin]), branded as Omnitrope, in the United States. That drug was approved under a special consideration from the FDA in 2006.