Proposed legislation aims to streamline biosimilar development and expand patient access

Representatives August Pfluger (R-TX) and Greg Landsman (D-OH) have introduced legislation aimed at reducing regulatory barriers and expanding access to affordable biosimilars for American patients. The bill seeks to make it easier for drug developers to bring lower-cost alternatives to market without compromising safety or effectiveness.

Biosimilars, which are highly similar to existing biologic medicines, have already generated significant savings for the healthcare system. Over the next five years, they could help Americans save up to $181 billion. However, a substantial ‘biosimilars void’ threatens these potential savings: only 10 percent of the biologics expected to lose patent protection in the next decade currently have biosimilars in development. The new legislation is intended to address this gap and support a sustainable and competitive biosimilars market.

“The Biosimilars Forum commends Representatives Pfluger and Landsman for their leadership in advancing policies that will make lower-cost medicines more accessible to Americans,” said Juliana Reed, executive director of the Biosimilars Forum. “This legislation aligns with current scientific evidence and regulatory practices, ensuring that patients benefit from the cost savings and expanded treatment options that biosimilars offer.”

The bill responds to the April 2025 executive order on lowering prescription drug prices, which highlighted the importance of biosimilars in reducing costs and fostering competition. By streamlining regulatory processes, the legislation encourages a faster path from development to market, allowing patients to access a wider variety of biologic treatments at lower prices.

Backed by more than 15 years of clinical experience and data from the biosimilars industry, the proposed legislation reflects the sector’s ongoing commitment to patient safety, efficacy, and affordability. By promoting innovation while reducing unnecessary regulatory hurdles, it aims to accelerate adoption of biosimilars and help address rising healthcare costs.

The Biosimilars Forum said it looks forward to working with Congress and the administration to support the development and uptake of biosimilars, improving healthcare affordability and expanding patient access across the United States.