With a nod to Dickens given that it’s the holidays, I’ve been thinking about biosimilars past, present and future lately. In that holiday spirit, even though the parallels aren’t perfect to the classic holiday story, let’s look at the biosimilar market of the past, the trends of present day, and where I would like to see biosimilars go in the future.
The Ghost of Biosimilars Past
Biosimilars are biologics that are highly similar to and have no clinically meaningful differences from their reference biologic. However, in the early days of biosimilars, they weren’t always widely used: their market share was low and many Food and Drug Administration (FDA)-approved biosimilars had been unable to launch. Experts had concerns that biosimilars would not effectively create competition with biologics to reduce prices because, at the time, biosimilars didn’t enter the market in large numbers, and there were uncertainties around the differences between biosimilars and biologics.
The tide for biosimilars slowly began to change. Prior to the launch of their biosimilar competitors, we had frequently seen list price increases for the reference biologics. As more biosimilars started to enter the market in 2018 and 2019, creating competition, many manufacturers of reference biologics stopped increasing their list prices. And for some of these biologics, the freeze in list prices was paired with decreases in net costs.
The Ghost of Biosimilars (Almost) Present
The promise of biosimilars is starting to pay off. New research, Improvements in Medical Benefit Coverage of Biosimilars, looks at trends in the commercial medical benefit and has found that in the past few years in three disease areas (breast cancer and non-small cell lung cancer, colorectal cancer and chronic lymphocytic leukemia, and neutropenia), not only has the price for biosimilars AND their reference biologics decreased, but coverage of biosimilars has also increased.
Average sales prices (ASPs) for biosimilars and their reference biologics declined up to 24.5% between 2018 and 2021, with some biosimilar prices declining faster than prices for their reference biologics. Biosimilar placement in commercial medical benefits also increased by 36.5% percentage points to a 92% coverage rate in 2021, meaning greater coverage of and access to biosimilars.
The Ghost of Biosimilars Future
The biosimilar market continues to grow, in terms of number of products, availability for self-administration, and uptake. Looking toward the future, PBMs are advocating for four key policy changes to reduce barriers to biosimilar adoption and increase biosimilar uptake:
- Remove the interchangeability designation to reduce health care system costs;
- Or in lieu of removal, encourage the FDA to declare that biosimilars should automatically be interchangeable with reference products;
- Enable plan flexibility to make midyear changes to formularies, replacing reference products with biosimilars not designated as interchangeable without additional permissions;
- Ban product hopping, patent thickets, and pay-for-delay; and
- Limit exclusivity for reference biologics to seven years.
In the biosimilars future, which PBMs hope is a robust one given that they have long known the value of biosimilars, physicians will be open to prescribing them, patients open to using them, and manufacturers will happily invest in them. Indeed, with the policies outlined above and their actions in the market, PBMs are supporting efforts to increase the number of biosimilars coming to market. That, in turn, will increase competition, drive down costs, and create choice for patients and their providers.
Learn more about biosimilars and PCMA’s policy recommendations on our PBMs Support and Encourage Biosimilar Competition website.
