Amanda Forys on the Development of the US Biosimilar Market

The US biosimilar market is developing, but its sustainability in the market is still unknown, according to Amanda Forys, MSPH, director of Xcenda’s Reimbursement Policy Insights consulting team.

Transcript (slightly modified)

Is the US biosimilar market developing how you expected it would?

Yes and no. The biosimilar market in the United States is a bit behind the rest of the world in terms of product availability. We’re getting a lot of lessons learned in seeing what’s going on in the European Union. But, the market here is starting to grow and starting to develop.

We are on the trajectory to have a lot of biosimilars come to market soon, we are just not there yet. There’s a lot of movement around oncology and rheumatoid arthritis products that’s really the big movement on biosimilars in the United States. We’re going to see a lot of products coming out for your typical Remicade, Humira, Enbrel, and Rituxan. Those are the 4 biggies that manufacturers are targeting in their biosimilar development.

The biggest concern with biosimilars coming to the market, and one of the things I work a lot in with our clients, is concern around the stability of the market and where we think it can go in the future. So, while we have got products coming to market there is a lot of concern around reimbursement and policy and coverage for these products and if it will be sustainable in the future. So, while we are growing and while we are developing and having all these products come in, we are not quite sure if we are going to have a market sustainable to keep them and keep manufacturers interested in pursuing that pipeline to get those products out into the market.

The biosimilars market is a bit different from the generics market. A lot of payers, a lot of people, or when you hear Medicare or MedPAC policy, or people coming out and talking about biosimilars—a lot of them get the concept that they are a little bit different from a generic and that it’s not an exact replica of its original product because you cannot make a replica of a living organism like when you create a biosimilar. Because of that, the pathway for approval can take a lot longer and be a lot more expensive. So, instead of the generics market where we are looking at a 3 to 5 year time investment to create a generic that is a $1-2 million cost for the developer to put to the market, biosimilars are an 8 to 10 year development time with a $100 million to $200 million investment. That can be pretty hefty price tag for this market and with a lot of the reimbursement challenges manufacturers may not be willing to go through this pathway for coverage or for the development of these products and that could, down the road—5, 10, 15 years from now—really slow down that pipeline.

I think we are there in that we want to have them in the market and I think people understand the value of them and the economics. Since everyone is talking cost and everyone is talking value, that’s there. But if we can put the right parameters around them to actually encourage that development and the subsequent uptake, that will really be where we are to determine if the US biosimilar market is vibrant like we are seeing elsewhere.