FDA BioSimilar Rules Tilt Us Toward BioBetters?

08/08/2011

FDA BioSimilar Rules Tilt Us Toward BioBetters?

Fierce Biotech today printed a story that effectively asks, "Is the FDA setting the bar so high for biosimilars that they can't be competitive in the US?

In an interview with Scientific American blogger Khadijah Britton, Aggarwal says that the FDA's latest stab at outlining the approval process for biosimilars highlights just how complex and expensive this will be. Add in an even tougher approval process that will be needed to achieve interchangeability-the right for pharmacists to substitute a branded biologic with a biosimilar--along with increasing signs that payers and providers won't settle for anything less, he adds, and you have a recipe for failure.

It looks like the lobbyists down at PhRMA are doing their job and the innovators will be getting regulations more to their liking -- at least if recent signals from FDA as to the form the regulations make take hold up. The provisions (i.e. clinical data generation) that will be needed to support interchangeability between the biosimilar and branded product look to be both extensive and expensive. Probably more expensive than all but th every biggest biosimilar producers would wish to take on. This will undoubtedly limit the competition if the final regulations go through like this. With more limited competition, and more upfront investment, it is unlikely that pricing effects (i.e. savings) will be as profound with biosimlars as is seen regularly with generics.

This leads me to wonder if a significant number of putative producers of biosimilars for the US market might not just be better off going the biobetter route. Afterall, the target will have been a proven one and knowledge as to how to better the final product will be there (or not) to allow one to make the decision to pursue more easily. And it looks like the time and expense to reach market might not be that radically different -- especially if measured against a biosimilar that achieved interchangeability status. We shall see if the balance shifts toward the biobetters option in the US when the new FDA regs are adopted.

Posted by Bruce Lehr Aug 8th 2011.