Time to Market Entry and Shallow Discounts Delay Biosimilar Savings, but Interchangeability Could Help

As the United States lags behind Europe and other highly regulated areas in terms of biosimilar approval and uptake, research presented during the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting in Baltimore, Maryland, points to slow market entry and small price discounts of approved biosimilar products as key factors that are holding up cost savings in the US market.

Researchers from the University of Tennessee presented results of a study that analyzed obstacles hindering biosimilar availability and uptake in the United States.¹ The study, which relied on an inventory of FDA-approved biosimilars, drug fact sheets, FDA guidance, and Truven Health’s Redbook, as well as patent expiration dates and drug prices, found that the actual (or anticipated) market entry of US biosimilars was a median of 6 months (range, 3 months to 76 months). In comparison, the median waiting time in Europe was 0 months (range, 0 months to 5 months).

Legal disputes, the authors say, as well as patent protection and settlements between biosimilar developers and reference product manufacturers, are principle drivers of long wait times for biosimilars to reach the market in the United States. Price discounts are also substantially smaller in the United States than Europe, they write; in the United States, biosimilars cost just 17% to 35% less than their branded counterparts.

Greater uptake of the biosimilars currently available in the United States—as well as interchangeability designations for those products—could produce significant savings; however, another research team, from the Manticore Consulting Group and the University of Connecticut, presented findings from a budget impact analysis of biosimilars in the United States.² The analysis used a 3-year time horizon, with cost and market share inputs from 2017 used for the 2 US-approved infliximab biosimilars, Inflectra and Renflexis.

The base case model assumed that there was no interchangeability between the reference Remicade and the 2 biosimilars, and 2 scenario analyses assumed interchangeability of the reference with the biosimilars, with price discounts varying from 20% to 35%.

The projected cost savings from the non-interchangeable biosimilars was $25.3 million over 3 years. Assuming interchangeability, cumulative savings over the same period could reach $38.3 million. If the market share for biosimilars grew from its 17% share in 2017 to 35%, biosimilars could result in a cumulative savings of $52.0 million without interchangeability, and $78.9 million with interchangeability, say the authors.

References

1. Phelps G, Wang J, Schwab CA, Li MS. Barriers impeding the availability and uptake of biosimilars in the US. Presented at the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting. May 22, 2018; Baltimore, Maryland. Abstract PHP41. ispor.org/ScientificPresentationsDatabase/Presentation/81206

2. Chopra AS, Chopra I, Giardina C, Arkells N. Shift in the status quo: how biosimilarity can lead to significant cost savings. Presented at the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting. May 22, 2018; Baltimore, Maryland. Abstract PHP85. ispor.org/ScientificPresentationsDatabase/Presentation/82246