WASHINGTON (AP) — Swiss pharmaceutical giant Novartis is urging the Food and Drug Administration to allow generic versions of biotech drugs to bear the same chemical names as the original products they mimic.
Basel-based Novartis said in a petition filed Wednesday that forcing generic biotech drugs to carry different drug names would change "well-established convention" and "undermine the safe and rational use of all biologics."
The FDA is starting to approve the first generic biotech drugs, or biosimilars, and Novartis is one of the key companies expected to compete in the space. A policy forcing biosimilar drug products to take new names could make them more difficult to market to doctors and hospitals.
In its petition, Novartis also argues that "an inconsistent application of naming conventions would lead to medication errors and jeopardize patient safety."
Companies routinely file petitions with the FDA on policy decisions that could affect their business and operations. The FDA reviews them and responds whether the agency will adopt the petitioner's recommendation.
Novartis, through its generic business Sandoz, markets biosimilar drugs in the U.S., Canada, Europe, Japan and Australia.
Since their introduction in the 1980s, biotech drugs did not face generic competition because the FDA did not have power to approve copies of the medications. For years the biotech industry successfully argued that their drugs, often made from living cells, were too complex to be duplicated by competitors.
That finally changed with the Obama administration's 2010 health overhaul, which ordered the FDA to create a system for approving so-called biosimilars. The industry term arose because biotech scientists insisted it would be impossible to produce exact copies of their biologically engineered drugs. They differ from traditional drugs, which are made by combining various chemicals.