A report from the IQVIA Institute for Human Data Science states that assessments of the health of the US biosimilar market are too conservative.
The pace of biosimilar development and uptake in the United States is much healthier than is commonly assumed, according to a report from the IQVIA Institute for Human Data Science, which predicts biosimilar sales of $80 billion over the next 5 years, as well as potential biosimilar-generated health care savings of more than $100 billion during that same period.
“Some commonly held assumptions about patient and provider acceptance and comfort with biosimilars appear to be more conservative than data demonstrate,” said the authors of the report.
Drugs representing 51% of spending on biologics currently face or will face biosimilar competition in the next 10 years, according to the report.
Recent launches of biosimilars for bevacizumab, trastuzumab, and rituximab molecules are set to achieve nearly 60% volume share by the end of their second year on the market, which is significantly higher and faster than previous biosimilar launches, the report said.
The FDA has approved 28 biosimilars for 9 drug types, and 18 of those biosimilars have been launched. However, the IQVIA report classifies biosimilars more broadly, including some agents that until recently were approved under the nonbiosimilar 505(b)(2) or 351(a) pathways, not the specially created 351(k) pathway under the Biologics Price Competition and Innovation Act.
IQVIA defines a biosimilar as a “nonoriginal biologic medicine produced through recombinant technology” and states that, by this standard, 33 biosimilars have been approved in the United States across 13 drug types. Of those, 22 have been launched and command a 20% share of the biologic spectrum of originator drugs for which there are biosimilars. This represents about 16% of biologic drug sales overall, IQVIA said.
IQVIA includes insulin glargine and insulin lispro agents among biosimilars, although these are not FDA-approved biosimilars. In these categories, “there are now very few, if any, additional biosimilars in development,” IQVIA wrote. This was attributed to the complexities of manufacturing insulin and deep discounts that enable dominant brands to retain market share.
IQVIA states that according to its own research, 108 additional biosimilars are under development for 22 other drug types.
Employment of biosimilars by providers is highly variable. A select group of providers uses bevacizumab biosimilars as much as 100% of the time. Some providers try to avoid switching patients from one product to another by treating with a biosimilar or the originator, but not both. A majority of providers use both originator and biosimilar products, according to the report.
“These differences reflect contracting approaches by manufacturers and providers, and prescriber willingness to adopt biosimilars including the associated issues with changing patient treatment protocols,” the authors wrote.
In some cases, biosimilar introduction has triggered 2% to 4% incremental demand for these agents, meaning that the use of biosimilars has led to greater use of the underlying drugs overall and greater access for patients, IQVIA said.
The report said biosimilars have generally caused 30% price declines, which are in line with earlier predictions, “though higher discounts have occurred and are possible in the future.”
The report said that large companies that have originator biologics of their own have entered the biosimilar arena and dominated it with biosimilars of their own. Smaller companies are developing biosimilars, too, but are likely to contract with larger companies for assistance in marketing those products, IQVIA said.
Although there are currently no insulin products officially approved as biosimilars, discounts and savings for follow-on or bioequivalent insulins to reference products, such as Lantus (insulin glargine) and Humalog (insulin lispro), have been achieved.
According to the report, patients with diabetes are saving an average of $17 per prescription with their health insurance when using a bioequivalent insulin, including an average savings of about $18 to $19 for those with Medicare and $13 to $14 for those with commercial insurance.
The price of Admelog (insulin lispro) is 45% lower than the originator, and the generic product launched by the originator manufacturer costs just 5% more than Admelog, allowing patients and plans 2 lower-cost options.
“Contrary to some predictions, biosimilars are not a failed concept; they are in fact becoming a growing part of affordable treatment options available to payers, physicians and patients,” said Murray Aitken, IQVIA senior vice president and executive director.
Aitken M, Kleinrock M, Muñoz E. Biosimilars in the United States 2020-2024: competition, savings, and sustainability. IQVIA. September 29, 2020. Accessed October 6, 2020. iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024