NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.
Next week, Sumant Ramachandra, the chief scientific officer of drug maker Hospira, will travel to Switzerland to speak at the World Health Organization about biosimilar naming, presenting a new policy paper titled "What's in a Name?: The Importance of Biosimilar Nonproprietary Names for Healthcare Innovation." Hospira is the only U.S.-based company that makes biosimilars for the European and Australian markets.
The paper and speech follow a citizen's petition to the Food and Drug Administration from the Generic Pharmaceutical Association encouraging the sharing of generic names between biosimilars and their reference products. For example, Amgen's Neupogen, used to replenish white blood cells in patients undergoing chemotherapy, and biosimilar versions of it would all use the same generic name, filgrastim. Biotech companies say that because biosimilars are similar, not identical to their branded counterparts, their generic names should be made different, such as carrying a prefix.
"Biosimilar naming is an extremely important issue for the United States," Ramachandra said. "With the U.S. Food and Drug Administration expected to approve the first biosimilar drugs by mid-decade, we need to make sure that we don't create unnecessary roadblocks, such as a confusing system of different non-proprietary names that potentially could limit access to more affordable biosimilar drugs."
Part of the issue involves a key difference between the relationship of biosimilars with their branded counterparts, and the relationship of generic drugs to branded drugs. While generic drugs are meant to be chemically identical to branded drugs, biosimilars are designed to be "highly similar" because they're produced using different cell lines from the originals, but have the same effect. According to Hospira, in Europe, where biosimilars have been available for six years, costs have fallen 25% to 30% after the introduction of a biosimilar.
“It is simple: Biosimilars have no clinically meaningful difference from the reference product, so they should have the same name,” GPhA president and CEO Ralph G. Neas said. “This approach works in Europe, it has worked in the United States for chemical drugs, and it should be the standard worldwide.