Biosimilars have been in the US for almost a decade. Out of 90 biosimilars that are approved by the FDA, 63 biosimilars have launched to date, representing 20 therapeutic reference products. Have biosimilars made a difference? “In the last decade, about $56 billion have been saved for US stakeholders due to biosimilar entrants,” says Thomas Newcomer, Senior Vice President and Head of US Commercial, citing the Association for Accessible Medicines report, during a keynote presentation at Reuters Pharma USA, held in Philadelphia, March 16-17.

“Biosimilars drive down price for everybody, but should price be the only thing that we are thinking about with biosimilars?” Tom asks. According to him, there are other variables that need to be evaluated, and it cannot be the price alone.

Total cost of care: Stakeholders should consider the entire cost of treating a patient over time, not just the drug acquisition cost per unit. For example, for ustekinumab, the cost of drug acquisition should not be just based on the maintenance dose, but also the loading dose which is administered once at the start of the treatment cycle. Total cost of care also includes the cost of drug administration (e.g., infusion, self-administration) and managing disease progression including complications, side effects, and hospitalization. Biosimilars can help reduce the total cost of care by allowing earlier access to the treatment, but there could be total cost of care differences even between the biosimilars which go beyond a unit price.

Supply continuity: Biosimilars are manufactured and supplied from diverse regions across the globe. Based on the past experience, global pandemics and geopolitical conflicts have imposed constraints on the global supply of medicines, which can ultimately affect patients that need to receive timely treatments. With global wars going on, stakeholders must evaluate where each product is manufactured across different stages of manufacturing, and whether each manufacturer has contingency plans to prevent supply disruptions, with back-up sites and efficient inventory and logistics management, as well as the history of stockouts.

Quality: While approvals by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) mean they are certified for use in patients, quality should not be taken for granted. Manufacturing of biologics requires stringent control and needs to be monitored consistently because biologics are sensitive to manufacturing changes. Manufacturers should be carefully evaluated for their historical quality records and whether strict control and governance are in place to maintain consistent quality batch-to-batch over time.

In addition, each manufacturer has different co-pay assistance and patient support program so the details should also be taken into consideration when evaluating a biosimilar product, according to Tom. “Every biosimilar will have a check box for patient support programs and what they look like individually is completely different. There are differences between these support systems to help patients; some may only offer video education, some may do live appointments, some may do virtual appointments, some may cover your co-pay to a certain dollar amount and some may do it indefinitely. Tons of differences when you dig down into each one of them.”

A lot of these variables get overlooked and stakeholders need to conduct a holistic evaluation in order to choose a product that is going to stay in the market for the long-term.

Biosimilars cost $100 to $300 million to develop, and for biosimilar companies to be assured that there is going to be a market for biosimilars in the future, they need to see better stability in what the market is going to be. “Right now, there is a massive void for the most high-spend medications for biosimilar development. Biosimilars enable manufacturers to take that money, invest in R&D, in future therapies. The healthcare system saves money (through biosimilars), and they can put that into another area to invest into the future. We need to continue to see these savings for the future viability of the healthcare system and also for continued innovation,” says Tom.

Thomas Newcomer’s Reuters Pharma USA presentation on ‘Navigating the Challenges and Opportunities of the US Biosimilar Market’ is available here: https://www.youtube.com/watch?v=NoPTrKvFPU4