You have to admit the innovators are doing a good job for their investors by pursuing every avenue at their disposal to block the quick introduction of biosimilars. You have arguments for clinical trials, you have arguments against the FDA accessing info in BLAs (see Abbott) and now you have naming conventions.
The PhRMA and BIO trade groups are petitioning the FDA to require each biosimilar to have a unique non-proprietary name, purportedly to aid in pharmacovigilance. These groups say they want to be able to distinguish between the original drug and the biosimilar to insure patient safety. But they really appear to want to put another hurdle in place that would prevent direct substitution or interchangeability - which of course should slow uptake of the biosimilar.
The GPA disagrees of course. It wants biosimilars to follow existing drug-naming convention which is used globally. It further notes that the same international non-proprietary name (INN) has been given to biosimilars in other countries and regions. They note that medical knowledge of biologics and safety information is associated with the INN and a unique name woudl cause decoupling -- and ironically potentially hurt patient safety. Plus, they note. There have not been a raft of safety issues with biosimilars in other geographies outside the US.
This debate boils down to money. And clearly, from a policy standpoint, if biosimilars are delayed in their introduction in the US, much of the cost savigs that patients (and the healthcare system) might derive will be blunted. Undoubtedly, successful launch of biosimilars will decrease prices for biologics (by how much?), but it should also increase uptake (volume) of these traditionally very expensive medicines in many parts of the world. The net effect remains to be seen...........
Posted by Bruce Lehr Jul 13th 2012.