Increasing Access to Biosimilars Act of 2023

Increasing Access to Biosimilars Act of 2023

This bill requires the Centers for Medicare & Medicaid Services to establish a demonstration project to evaluate the benefits of providing additional payments to providers of biosimilars under Medicare. Specifically, under the demonstration project, participating providers receive an additional payment based on the difference between the costs to the provider of furnishing the biosimilar and the cost if the provider had furnished the underlying reference biological product instead.

Bill 118 hr 1352, also known as the Increasing Access to Biosimilars Act of 2023, aims to improve access to biosimilar medications in the United States. Biosimilars are biological products that are highly similar to, and have no clinically meaningful differences from, existing FDA-approved biologic medications.

The bill seeks to increase competition in the biologics market by streamlining the approval process for biosimilars and reducing barriers to entry for manufacturers. This would help lower costs for patients and increase access to life-saving medications.

Key provisions of the bill include: 1. Allowing biosimilar manufacturers to rely on FDA-approved reference products for certain data, reducing the time and cost of development. 2. Establishing a pathway for interchangeable biosimilars, which can be substituted for the reference product without the intervention of a healthcare provider. 3. Providing incentives for healthcare providers to prescribe biosimilars, such as reimbursement incentives and education programs. 4. Improving transparency and communication between the FDA, manufacturers, and healthcare providers to ensure the safety and efficacy of biosimilars. Overall, the Increasing Access to Biosimilars Act of 2023 aims to promote competition, lower costs, and increase access to biosimilar medications for patients in the United States.