Dr Aimee Tharaldson Expects the Biosimilar Approval Process to Pick Up Speed

The process for approving biosimilars has been moving slowly, but Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapies at Express Scripts, foresees them as having the potential to lower costs for the industry and hopes the approval process will pick up speed.

The process for approving biosimilars has been moving slowly, but Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapies at Express Scripts, foresees them as having the potential to lower costs for the industry and hopes the approval process will pick up speed.

Transcript (slightly modified)

A second biosimilar has been approved in the US: how has the process of getting biosimilars approved been going?

I think the process for getting biosimilars to market has been slower than I expected. The 351(k) pathway was established in 2010 as part of the Affordable Care Act. FDA has been releasing draft guidance documents over the past 5 to 6 years, and the first biosimilar was approved 5 years after the pathway was established. Now we just had the second biosimilar approved this year, but we don’t know when that will be launched.

So I think, initially, it’s just been taking a lot of time as there are so many different stakeholders with conflicting interests, as well as the litigation is just going to be a major hurdle to getting these products to market. So it’s been a little bit slow, but I think that it will speed up in the future.

Do you think biosimilars will have a significant impact on lowering cost?

I think initially these biosimilars will be treated more like competing brands just because there aren’t going to be a lot. Pricing at this point seems like they may be about 15% less than the reference biologics so that’s not a huge discount. I do think that over time, once we have more competitors in the market, more biosimilars—hopefully interchangeable biosimilars—that that will really have a significant impact on lowering costs.

When you look at cost of specialty medications—Enbrel and Humira are huge medications and with biosimilar competition coming, I mean, they definitely have the potential to lower costs for the industry.