Biologics, especially antibodies, are important cancer therapeutics that have significantly improved outcomes for a number of solid tumors. However, biologics are considerably more costly than small-molecule drugs; in part because they are more complex to manufacture, and also because there has been very little competition, resulting in high costs for insurance providers and limited access for some patients. With the patents for many biologics expiring, the world of biologics has been changing. Biosimilars – biologics that are highly similar to and have no clinically meaningful differences from an existing biologic medicine (known as reference product) that is already licensed by the U.S. FDA – offer opportunities for additional players to enter the market, which should increase access and provide lower cost options.
Biosimilars have been approved in Europe since 2006 and in the US since 2015. Currently 84 biosimilars are approved by EMA and 35 by FDA. A recently updated list summarizes the approved biosimilars. It also indicates those that were approved in Europe and later withdrawn. Clearly, the regulatory and marketing realities for biosimilars are complex.
So, have biosimilars reduced the cost of drugs? They have, but for now savings appear to be modest. For example, an interesting article on goodrx.com states that in 2020 the list price for one month of Avastin (anti-VEGF) was $11,954 whereas the two FDA-approved biosimilars, Mvasi and Zirabv, cost $10,161 and $9,201 per month, respectively. The price for Herceptin (anti-HER2) was $4,675 per month and 4 approved biosimilars (Kanjinti, Trazimera, Ogivri, and Herzuma) were priced only 10 – 15% lower between Herceptin.