Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, discusses the challenges that biosimilar developers face in getting their products to market.
What are some of the biggest challenges in getting a biosimilar to market from a manufacturer’s perspective?
Well, I think it starts with the intellectual property (IP) situation in the United States, right? It's so different, and it's kind of a unique situation in the United States. You know, usually the [United States] leads innovation. In the case of biosimilars, we're about 10 to 12 years behind the rest of the world, largely because of the IP situation and what we call the "patent estates" that a number of the originator companies have been able to put up.
The second big sort of challenge and obstacle, I think, has been in the past more of a policy sort of challenge where biosimilars were to some extent disadvantaged, whether it was through CMS or the FDA, and other things. So, from a policy perspective, just in the last 6 months I never could have imagined that we would have seen some of the policy solutions that have been put forward by the government.
So we've resolved some of those to at least I would say get biosimilars to be equivalent to the originator. I think our hope now is, is there not a policy opportunity for us to now maybe enable biosimilars by giving them more of a favorable sort of policy pathway, and certainly that's the energy that we're feeling from [FDA Commissioner Scott Gottlieb, MD] and other officials in the government is to try to now really enable the biosimilar uptake.
And then the final one, I think, is really the system in the United States with what everyone's referring to today as the “rebate wall” certainly is a big hurdle for us in terms of "how do we overcome that?" And, again, I think Americans are looking for a lot more transparency. It's a very complicated system compared to other countries. But, you know, we're now at a stage where we have at Sandoz 86 countries where we've been successfully marketing biosimilars.
The time feels right to us that some of these challenges will start knocking down pretty quickly. I think the [United States] is definitely ready to free up the capacity to fund these innovations. I mean, you know, even in oncology when you think about what's happened from an innovation perspective in the last 5 years, if we don't create the room in the marketplace to take advantage of these savings now, then we're not going to be able to have access to these new innovations, and I think that's what really excites us the most at Sandoz in terms of the value that we can create for Americans in the US healthcare system.