Biosimilars: Uptake and Pricing in the US, Germany, and Switzerland

Biologics, complex drugs derived from living cells, represent a significant share of health care expenditures. They majorly treat cancer and other medical conditions, accounting for a substantial portion of health care spending, according to a study published in JAMA Network Open. In the US, while they make up only 2% of prescriptions, biologics contribute to 37% of net drug spending, making them a costly health care segment. With patents for some biologics expiring, there is a shift toward biosimilars, which are highly similar but not chemically identical to approved biologics, offering potential cost savings and greater competition in the market.

Various countries have implemented policies and regulatory pathways, such as the US's Biological Price Competition and Innovation Act and a similar approval pathway in the European Union, to facilitate the entry of biosimilars. This study used publicly available data to assess the uptake of biosimilars in the US, Germany, and Switzerland. The research revealed that biosimilars are gaining traction in all three countries, but the uptake varies among different active ingredients and across the nations. Generally, Germany had the highest average biosimilar market share, followed by the US and Switzerland.

The prices of biosimilars compared to reference products showed variations between the countries. In the US, biosimilars initially had lower relative prices than reference products, while in Germany, prices for certain biosimilars were higher. Switzerland saw lower relative prices for biosimilars. Monthly treatment costs for biosimilars were higher in the US than in Germany and Switzerland.

The study suggests that patent disputes and exclusionary contracts may influence the availability and pricing of biosimilars in the US. In particular, some reference products had extensive patent protection, which delayed biosimilar market entry. The study emphasizes the importance of timely market entry and pricing negotiations to increase biosimilar uptake and reduce health care costs.

"Policies for drug pricing negotiations in the US against anticompetitive practices of exclusionary contracts could allow biosimilars to enter the market sooner and at lower costs, which could result in lower health care costs and improved patient access. Awareness of biosimilars should be promoted to increase the uptake of biosimilars in all three countries," said researchers.

Reference

Carl DL, Laube Y, Serra-Burriel M, Naci H, Ludwig WD, Vokinger KN. Comparison of uptake and prices of biosimilars in the US, Germany, and Switzerland. JAMA Network Open. 2022;5(12):e2244670. doi:10.1001/jamanetworkopen.2022.44670