With recent concerns about the skyrocketing cost of prescription drugs and biologics, attention has turned to whether the biosimilar market may provide some relief, at least in the realm of often very high cost biologics. To date, few biosimilars are available, but that is likely to change in the coming months.
In 2009, Congress passed the Biologics Price Competition and Innovation Act, creating an abbreviated marketing approval pathway for biological products that are biosimilar to or interchangeable with a biological product that has already received US Food and Drug Administration (“FDA”) approval. Six years later, in 2015, Sandoz’s Zarxio, which is biosimilar to Amgen’s Neupogen, became the first biosimilar product to be approved under that pathway. Since that time though, there have only been 25 additional biosimilars to achieve FDA approval, for a total of 26 approvals.
However, only a fraction of those 26 approvals were on the market at the end of 2019. For instance, there have been 5 biosimilar approvals for Abbvie’s Humira, but none of those is actually on the market in the US. According to Abbvie, direct biosimilar competition for Humira in the US is not expected until 2023.
Furthermore, biosimilars that have entered the market have not fared well. For instance, Johnson & Johnson’s Remicade, has two biosimilar competitors – Inflectra and Renflexis. However, those biosimilars have only managed to garner a combined 12% market share.
However, former FDA Commissioner Scott Gottlieb, MD, expects this to change. He notes that the market share of biosimilars is growing and this is “leading to meaningful price erosion over time; with the more recent biosimilar launches showing a lot of success.” Gottlieb suggests that this may be due to “the growing marketing sophistication” of the biosimilar manufacturers. Gottlieb also acknowledges that US adoption of biosimilars has been much slower than adoption in Europe, noting challenges in the selling model, but suggests that “allowing Part B drugs to be competitively bid like under Part D” will improve the situation. Gottlieb also recommends banning anti-competitive rebating in markets where biosimilars have entered.
Pfizer is positioned to make huge inroads into biosimilars markets with two launches slated for January 2020 – Zirabev and Ruxience. The reference biologic for Zirabev is Genetech’s Avastin, which is a treatment for cancer. The reference biologic for Ruxience is Genentech’s Rituxan, also a cancer treatment. Following on these launches, Pfizer is expected to launch a third cancer biosimilar, Trazimera, referencing Genentech’s Herceptin, in February 2020.
Also, as noted above, Humira biosimilar launches are expected in 2023. Humira biosimilars have taken hold in Europe, acquiring 35% of the market share in just one year. If Gottlieb’s predictions are correct, the US will have a more European-looking biosimilars market going forward.