Did you see the score? The US is down 2-20 against the EU. That sounds like an unfortunate soccer season, with the US in last place (or headed toward the worst single-game defeat in US history). Sadly, this is not a sporting event- we are talking about biosimilars, and the US is seriously lagging as the EU takes an 18 point lead. Currently, the FDA has only approved 2 biosimilars compared to the 20 biosimilars approved by the EMA for patients in Europe. The first US biosimilar launched in 2015, and the second launched this year.
As explained by FiercePharma, “[a]ccording to the Congressional Budget Office, biosimilars are expected to save $13 billion over the next 10 years. Initially, from the payer perspective, biosimilars were expected to generate 30% to 40% savings” compared to existing treatments. The pharmaceutical industry is continually challenged internally to reduce production costs, but also externally to provide affordable alternatives that reduce costs for patients. Since biosimilars seem like a promising solution, the important question is: why have only 2 biosimilars been approved by the FDA? According to FiercePharma, here is the catch: “as the complexity of bringing biosimilars to market continues to be discussed, more recent data suggest that most payers anticipate a biosimilar will come in between 10% to 20% less than the cost of the branded manufacturer. In Europe, we know that biosimilars have often been just a 10% discount from the brand.” There is more than meets the eye, and right now the industry is balancing a wide range of different concerns from patient safety to costs, processes, and more.
We’ve got to give the US a little more credit because it’s on everyone’s radar that the potential of biosimilars is endless. As mentioned in our 7 Things to Know About Biosimilar Drugs post, it is a fast growing segment. That seems to be what the FDA is waiting on. Do they want more data? How many have they denied? Leah Christl, Ph.D., Associate Director for Therapeutic Biologics at FDA predicts, “Biosimilars are likely to create greater competition in the medical marketplace.” The potential of this market is going to drive growth and increase competition. All of these things are good for the patient and good for manufacturers. This will result in increased treatment options for consumers, which will ultimately lead to more affordable alternatives. Seeing potential, the industry is in hot pursuit as many companies rush to develop new treatments.