Fierce Biotech writes this morning that Sandoz is moving ahead with a full slate of 7 new biosimilars, including a ballyhooed launch of a phase III trial with its version of Enbrel. This despite the fact that the US FDA has yet to finalize its rules governing the introduction of biosimilars, and the fact that Amgen announced it had secured a patent extension on Enbrel that would protect its franchise drug for up to 17 more years past its 2012 main patent expiration.
Other companies like Merck and Lonza/Teva have recently backed off or slowed down biosimilar programs that they were pursuing. Presumably due issues like Amgen's patent, and an uncertain regulatory environment. The latter being particularly true if the US is going to require a lot of expensive phase III trials to get new biosimilars on the market. Lonza's CEO has alluded to that as possibly shifting the economics to be less favorable than previously thought.
However, Sandoz is plowing full speed ahead. Why? I think it is simple. Many governments around the world, and I think the US government feels similarly, have made it clear that they want to do something to reign in healthcare costs. While drugs in general are cheap on the grand scale of things, certainly compared to other elements of healthcare, they do present an inviting target for payers. And what appears to be a bigger target than biological drugs with their 10's to 100's of thousand dollar price tags for a patient in a single year? Not much is so easily seen and seemingly easily controlled by offering a biosimilar alternative -- especially if this is seen as being analogous with generics and small molecule drugs.
It's simple. It's the savings stupid. As long as governments' smell savings, policies will be implemented to make sure biosimilars make it to market one way or another. This is particularly true in the East and developing portions of the world that WON'T bear the big price tags. That's why Sandoz is making its press.
Posted by Bruce Lehr June 24th 2013.