The U.S. Food and Drug Administration (FDA) has announced new measures intended to reduce time and costs associated with the development of biosimilars, which are lower-cost alternatives to biologic medicines used in the treatment of chronic and serious conditions.
In a new draft guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies,” the FDA has proposed updates to simplify biosimilarity studies and reduce the need for comparative clinical efficacy trials. The agency stated that comparative efficacy studies, which cost on average $24 million and take one to three years to complete, have shown low sensitivity relative to other analytical assessments. The updated guidance allows developers to rely more heavily on analytical testing.
The FDA also outlined plans to reduce the need for “switching studies” for biosimilars seeking interchangeability status with reference biologic drugs. These studies, which are not required for generic drugs, have been identified as contributing to development delays and confusion among patients and healthcare providers. The agency now generally does not recommend such studies.
Biologic drugs represent about 5 per cent of prescriptions in the U.S., but account for 51 per cent of total drug spending as of 2024. Although the FDA has approved 76 biosimilars since the first approval in 2015, their market share remains under 20 per cent. In comparison, the number of approved generic drugs exceeds 30,000. Only about 10 per cent of biologics expected to lose patent protection in the next decade currently have a biosimilar in development.
The biosimilar approval pathway was created under the Biologics Price Competition and Innovation Act (BPCIA) in 2010 to encourage competition in markets with high-cost biologics. The FDA stated that the new measures aim to increase biosimilar availability, support competition, and lower patient costs.
Commenting on the development, Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance, said:
“The recent announcement by the USFDA and CMS is a welcome step that will accelerate biosimilar development and lower drug costs for patients. The simplification of interchangeability guidelines and approval pathways will create a more enabling environment for the industry to diversify in large-molecule space. India already has nearly 130 approved biosimilars, and over the next seven years, more than 55 blockbuster drugs are expected to lose exclusivity in the US. India has long been a trusted partner in ensuring access to quality-assured, affordable medicines for American patients. These reforms will further strengthen the US–India partnership and our shared goal of improving healthcare access and affordability.”
(This is an evolving story and will be updated.)