A viewpoint recently published in JAMA explains why the biosimilar drugs approved in the United States for treating chronic diseases may not result in the expected cost savings and outlines steps that can be taken to increase the market share of biosimilars.
The viewpoint outlines the history of biosimilars in the United States, from the first approval in 2015 to the present day, when 4 biosimilars have been approved for treatment of 23 indications. [The fifth biosimilar was only recently approved in the United States.] The biosimilars field is expected to expand significantly in the coming years, as patent exclusivity for biologics accounting for $100 billion in sales per year will expire by 2020.
Observers have hoped that this expansion will manifest in the kind of savings seen with small-molecule drugs, where price decreases by an average 70% in the 2 years after a generic is approved, but the viewpoint explains that biosimilars for chronic diseases “are unlikely to yield widely expected cost savings” for 3 reasons:
The viewpoint offers 3 potential solutions to address these 3 obstacles. First, it recommends that more states pass laws allowing pharmacists to substitute biosimilars that have been labeled interchangeable by the FDA, which could “bolster competition, lower prices, and increase biosimilar availability.” Next, it recommends taking cues from Europe, where biosimilars have more successfully penetrated the market, by amending treatment guidelines to recommend biosimilars, approving more biosimilars, and enacting automatic switching laws.
Finally, the viewpoint author writes that legislators in more states should propose laws to encourage drug price transparency, particularly concerning rebates. This would educate patients on how the complex system of rebates influences their course of treatment and ensure pharmaceutical companies are held accountable for price increases.
The author notes that the hurdles encountered by biosimilars are similar to those faced by generic drugs over 30 years ago; now, generic drugs are widely accepted by patients and prescribers as a safe and cost-effective treatment option.
“Once the same is true for biosimilars, the health care system will likely realize significant savings,” the viewpoint concludes.